For more information regarding problems involving dry eye, see  Researchers Admit to High Incidence of Long-term Pain Following Refractive Surgery

If you would also like to receive some free wine "glasses" with LASIK, contact Dr. Dornic at

3701 NW Cary Parkway, Suite 101
Cary, North Carolina 27513
(919) 439-1174

Clinical psychologist Roger Davis, who also suffers adverse effects from Lasik surgery, called for an end to, or at least a moratorium on, refractive eye surgery. “Research connecting complications to quality of life provides the ethical basis for informed consent,” he said. “Because this research does not yet exist, refractive surgery cannot be performed ethically, whatever its satisfaction or complication rate.” Davis charged that, all too often, Lasik patients have not been afforded the opportunity to give “real” informed consent to surgery; that the Lasik industry has lied to the public about the nature of risk, and has sought to suppress public awareness of the severity of Lasik injuries in order to maintain public perception of the procedure as safe; and that, given this perception, many injured patients will begin to think of themselves as victims of a medical conspiracy. “Patients feel helpless to communicate their problems, and hopeless in getting the industry to do anything to solve them,” he said, pointing out that helplessness and hopelessness are cardinal features of depression and suicidal ideation.

Former Navy psychiatrist now in private practice Jennifer Morse testified that, however debilitating the adverse events associated with Lasik surgery may be, suicide should never be attributed to a single cause. “Suicide is a product of multiple factors — an individual’s background, personality, coping skills and genetic predisposition,” she said. She asserted that there is no direct cause-and-effect between suicide and adverse effects that can be attributable solely to Lasik surgery. She did, however, call for more research on quality-of-life issues, including patients’ pre-operative and post-operative perceptions of the effects of surgery. “We need to understand the reasons for dissatisfaction, pre-operatively, and steer some patients away from surgery,” she said.

The “no cause-and-effect” assertion by Morse was vigorously disputed by Michael Mullery, also a physician with credentials in the field of psychiatry. Referencing findings of a recent comparative study of suicide among hearing- and sight-impaired individuals, Mullery stated flatly that in some documented cases “Lasik sight loss is the sole cause of suicidality.” He also called for more psychometric studies on the effects of post-surgical sight impairment, and a moratorium on Lasik surgery until such studies are done. Several individuals offered poignant testimony to the alleged link between the act of suicide and Lasik surgery gone bad, including reference to suicide notes from family members expressly relating the act to frustration and despair over their medical condition.

Although FDA recently announced a partnership with the several Lasik surgeons’ organizations, including the American Society of Cataract and Refractive Surgery, to study Lasik safety and quality-of-life issues, critics of the agency complain the partnership represents an inherent conflict-of-interest, and they call for any such research to be conducted by an independent body. Michael Patterson, who has suffered severe adverse results from Lasik surgery, which he attributes to lax FDA oversight of ambulatory surgical facilities and, more specifically, to improper re-use of a single-use microkeratome device, expressed skepticism over the integrity of the FDA/Lasik industry partnership.

Several presenters offered testimony pointing to an exceptional degree of satisfaction with Lasik surgery, as revealed in meta-analyses of the medical literature and patient surveys. Medical University of South Carolina ophthalmology professor Kerry Solomon cited results of a comprehensive review of the world literature since Lasik surgery’s inception. Of 1,581 articles reviewed, Solomon said 19 dealt specifically with patient satisfaction, indicating that more than 95% of patients report satisfactory results with Lasik, even after five years, post-op. This finding is consistent with data presented by U.S. Navy Refractive Surgery Program director David Tanzer,  who reported that more than 98% of naval aviators who have undergone Lasik surgery say they are either “extremely satisfied” (90.9%) or “moderately satisfied” (7.2%) with their results. Tanzer said the procedure is voluntary for members of all the armed services, and is made available, not only to aviators, but to Navy divers, and members of Ranger and Special Forces units who are routinely subjected to the most rigorous physical demands.

Although the 95% patient-approval statistic for Lasik surgery seems generally accepted, critics pointed out that, even if “only” 5% of individuals suffer unacceptable results, considering that 700,000 surgeries are now performed annually, this would nevertheless constitute a public health problem of enormous dimension. In any case, Patterson and others insist no one really knows the full extent of Lasik-associated problems, charging that FDA has received only 140 adverse event reports in its database — a figure that, they assert, represents an absurd undercount. Miami-based optometrist Edward Boshnick, an expert on corneal refractive therapies, said that in his practice alone he has seen at least 200 patients with adverse results from Lasik surgery.

The public testimony was followed by presentations from FDA officials who described several Lasik-related agency activities, including requirements for pre-clinical studies, device labeling considerations, refractive laser and ophthalmic standards, and post-market and quality-of-life assessments. Of particular interest, CDRH chief ophthalmic medical officer Eva Rorer said the agency has recently assumed an “integral role” in the design of a quality-of-life (QOL) instrument, or questionnaire for Lasik patients, to be used in conjunction with clinical trials conducted by FDA and its sister agency, the National Eye Institute.

As the purpose of the advisory panel meeting was to inform panel members of public concerns with respect to Lasik-related issues, and to apprise them of FDA activities in this area, there were no votes taken by the panel. FDA officials responded to questions posed by the panel, and a number of comments and suggestions were offered by panel members for consideration by the agency. Medical College of Wisconsin chairman of ophthalmology Dale Heuer observed that FDA’s informed consent document, for use in clinical trials, may not be understood by some patients, and should be written at a high school reading level; University of California, San Francisco professor of clinical Ophthalmology Stephen McLeod offered criticism of the FDA Lasik Web site, suggesting that it include statistics on adverse events and links to other Web sites relevant to Lasik surgery.

The session was concluded by panel chair Jayne Weiss, ophthalmology professor at Detroit’s Kresge Eye Institute. She thanked all presenters and said her sense of the meeting was that, while Lasik has been of great benefit to a large majority of patients, the problems experienced by some are very real. She acknowledged that the Lasik industry may be fairly accused of “aggressive marketing” (“Lasik sold as a commodity instead of a procedure”) — a situation which she said may, indeed, suggest scrutiny by the Federal Trade Commission; and she said that there is need for more attention to the issue of “adequate” informed consent from prospective Lasik patients.

Unaddressed by anyone other that Patterson was the need for a CDRH compliance program to increase adverse experience or Medical Device Reporting accountability by end-user Lasik device (surgical) facilities.

Source:  FDAWeb.com

GAITHERSBURG, Md. - More than 200 people filled a conference room this morning to listen to report after report from patients suffering from complications of vision-correcting eye surgery.

In the first hour of a public hearing, more than a dozen patients and patient advocates stepped to the microphone to tell an advisory panel of the Food and Drug Administration about their years of eye pain, night driving problems and suicidal thoughts.

"You have a serious problem on your hands," said Michael Patterson, a lasik patient from Atlanta.

Patterson and others asked the FDA to stop lasik, which stands for laser-assisted In situ keratomileusis. They also asked for stronger warnings about the surgery's risks and urged the FDA to better track complications and to monitor false claims in surgeon's advertisements.

Some also questioned the impartiality and expertise of the panel. Patterson pointed to one panel member, Dr. Andrew Huang, a professor of ophthalmology at Washington University in St. Louis, and shouted, "We don't need your expertise."

Patterson claimed Huang failed to follow safe lasik procedures during surgery.

Among those attending were lasik patient Matthew Kotsovolos and his wife, Beth, of Raleigh.

Matthew Kotsovolos, who experienced debilitating complications after lasik surgery, called the hearing a sham. He referred to a news release put out by a trade group for laser surgeons claiming that the FDA considers lasik to be safe and effective.

Beth Kotsovolos told the panel that because of lasik, her children almost lost their father.

The FDA panel could recommend changing regulatory guidelines for the vision-correcting laser or it could do nothing.

The American Society of Cataract and Refractive Surgery has said that only about 3 percent of lasik patients experience complications, but other data and research suggest problems may be more common and long-lasting. sabine.vollmer@newsobserver.com or (919) 829-8992]]> 2008-04-24T11:31:02Z 2008-04-24T06:31:02-06:00 tag:www.lasikfraud.com,2008:/news//1.195 2008-04-24T11:31:02Z

Meant to be a cure for his eyesight problem, a laser surgery to correct Jermaine Dupri's vision has backfired. Reports are surfacing that the producer who is also known to be Janet Jackson's long-term boyfriend, is losing sight due to complications from the surgery.

Dupri had an elective eye surgery two weeks ago and according to a report by MediaTakeOut, sources said that Dupri is "virtually blind". Other details regarding this matter or any public statement from his publicist are not yet released.

Dupri posted the video of him getting the Lasik surgery on his YouTube account. He had forgotten his wallet and asked Janet who allegedly was in the middle of a rehearsal to pay for the bill. After the surgery that is supposed to be a minor one, Dupri reportedly did not attend the scheduled February 23 gig on Atlanta's V-103.

The first public hearing on how complications from laser eye surgery affect a patient’s quality of life will be held from 8:30 a.m. to 5 p.m. Friday, April 25, at the Gaithersburg Holiday Inn in Gaithersburg, Md., according to a notice published today in the Federal Register.

Laser eye surgeons who are collaborating with the Food and Drug Administration to collect patient information hope to have three of their colleagues testify. Patients dealing with complications from lasik — which stands for laser-assisted in situ keratomileuses — have also requested to speak at the hearing.

Patient petitions to more closely scrutinize lasik prompted the FDA two years ago to take another look at the medically unnecessary surgery, which is only loosely regulated. Testimony given at the public hearing may become part of a large, national study the FDA wants to conduct.

sabine.vollmer@newsobserver.com or (919) 829-8992.
SOURCE:  www.newsobserver.com/business/story/1011418.html

As federal regulators prepare to hold their first hearing on how complications from laser eye surgery affect a patient’s quality of life, patients are worried that they are being shut out.

The Food and Drug Administration has said it will hold a public hearing on the issue this spring, but patients who have requested to speak at the event cannot get  confirmation from the FDA on the date, time or location, said Michael Patterson, a lasik patient from Atlanta.

However, at least one laser eye surgeon who is working with the FDA to collect patient information plans to report his findings at an FDA meeting April 24-25.   And Dr. Richard Lindstrom, co-chairman of the group of surgeons collaborating with the FDA, said his group hopes to have three surgeons testify.

“The April meeting is shaping up to be a major hearing,” he said. Lindstrom also is president of the American Society of Cataract and Refractive Surgery, which represents about 9,000 ophthalmologists specializing in laser eye surgery.

The FDA has yet to publish meeting details in the Federal Register. Until it does, it is barred from making the information public, FDA spokeswoman Karen Riley wrote in an e-mail message.

The FDA’s response to patients’ requests for permission to speak, including his own, has Patterson worried that “the FDA is going to listen to the doctors, not the patients.

“It shows a lack of respect for patients,” he said.

Patterson experienced debilitating complications after his lasik surgery in August 2000, including dry eye, vision distortions and floating debris. His petitions to more closely scrutinize lasik — which stands for laser-assisted in situ keratomileusis — prompted the FDA two years ago to take another look at the medically unnecessary surgery, which is only loosely regulated.

Since the mid-1990s, numerous studies have suggested that the surgery is safe and successful in most cases and has become more so with the introduction of new technology.

The American Society of Cataract and Refractive Surgery has estimated that 2 percent to 3 percent of lasik patients experience complications, which typically resolve themselves in three to six months.

FDA statistics and other research indicate that complications, which can include chronic pain, dryness of the eyes and distorted night vision, may be much more frequent and longer lasting.

Takes a toll on patients

Patient advocates have long argued that the existing research is at best incomplete, because most studies do not evaluate how complications from lasik can affect patients’ lives.

At least one suicide has been linked to complications from lasik, bolstering patient advocates’ position that unremitting eye pain or impaired vision can exact a severe emotional toll.

Laser eye surgeons are willing to learn from patients’ experiences, Lindstrom said: “We need to understand the negatives.”

The first step is a review of 19 studies measuring patient satisfaction. Dr. Kerry Solomon of the Medical University of South Carolina’s Storm Eye Institute said he plans to report first results of the literature review at the FDA’s April meeting.

Of about 2,000 patients who participated in the 19 studies, an average 4.8 percent were not satisfied with the outcome of their laser eye surgery. In the study with the lowest satisfaction rate, more than 12 percent of patients were unhappy. The study with the highest satisfaction rate had no dissatisfied patients.

Patient satisfaction is a broader measurement than the complication rate, Lindstrom said. “It captures patients who objectively have a good outcome, but they’re not happy,” he said.

Patterson and other patient advocates disagree, saying that approach blames the patient rather than the surgery.

The toll from lasik complications is very real, Patterson said. And no matter how inconvenient regulators and surgeons make it for patients to argue that point, he said, “they’re not going to be able to shut us out.”

sabine.vollmer@newsobserver.com or (919) 829-8992
SOURCE:  www.newsobserver.com/business

Patients who undergo vision-correcting laser eye surgery sign a release form with an extensive list of risks, but some researchers and former patients say a potential complication is not mentioned: depression that can lead to suicide.

In response to patient complaints, the Food and Drug Administration plans to convene a large, national study to examine the relationship of lasik complications and quality of life, including psychological problems such as depression.

Malvina Eydelman, an ophthalmologist with the FDA’s Center for Devices and Radiological Health, wrote in an e-mail message that the scant clinical data available “failed to suggest significant problems following lasik surgery,” but she said the FDA wants a broad and systematic review. She wrote, “We also noted that quality of life issues related to lasik had not been evaluated consistently, and there were few reports of well-designed studies.”

Frustration and even sorrow can follow any unsuccessful surgery, but when the procedure leaves a patient with unremitting eye pain or permanently impaired vision, the emotional toll can be particularly severe.

One who could not endure it was Colin Dorrian, 28, a patent lawyer and aspiring medical student from suburban Philadelphia. He committed suicide last summer, 6 1/2 years after lasik surgery left him with lasting visual distortions. The surgery was done at a lasik center in Canada that has since closed.

“If I cannot get my eyes fixed, I’m going to kill myself,” he wrote in a note police found on his body. “I just cannot accept the fact that I’m supposed to live like this.”

In the note, Dorrian wrote that there had been other instances when he felt down. “I have other problems like most people do. But this is something else,” he wrote. “As soon as my eyes went bad, I fell into a deeper depression than I had ever experienced, and I never really came out of it.”

Laser eye surgeons who treat patients with complications say they do come across cases of depression, but they don’t think lasik complications are the root cause. They say patients who exhibit depression after the procedure were likely depressed or psychologically troubled beforehand.

“There’s no cause and effect,” said Dr. Steven C. Schallhorn, the former head of the Navy Refractive Surgery Center in San Diego and an expert on permanent visual distortions from lasik.

In September, The News & Observer reported on complications from lasik, a lightly regulated surgical procedure widely promoted as a quick and painless way to eliminate the need for eyeglasses. But patients across the country and in laser eye surgery hot spots such as the Triangle, where 11 laser eye surgery centers operate, say the physical after-effects can cause or aggravate psychological problems.

Martha Walton of Raleigh postponed lasik twice. She had had bouts of depression and anxiety attacks and wasn’t sure she was ready for the permanence of eye surgery. She still felt very anxious when she went ahead with it in August. Within a month, Walton, 41, a high school teacher, developed constant, severe pain from eye dryness. She couldn’t cope with it and spent six days on suicide watch in a Triangle mental health facility.

“I was in so much pain,” Walton said. “Twenty-four hours a day there was no escape. The only relief I could think of was to end my life. At least the pain would be over.”

An elaborate regimen of taking supplements, wearing special goggles and switching to preservative-free eye drops has drastically reduced her pain. But her eyes still do not produce enough tears and she continues to take daily anti-anxiety medication.

Christine Sindt, an optometrist and associate professor of clinical ophthalmology at the University of Iowa in Iowa City, Iowa, has encountered the psychological effects that patients experience when they have trouble seeing.

“Depression is a problem for any patient with a chronic vision problem,” she said. But in the case of post-lasik patients, she said, the depression is compounded by remorse.

“It’s not just that they lose vision,” she said. “They paid somebody [who] took their vision away.”

Sindt specializes in treating ectasia, a bulging of the eye that is considered the most severe and rarest lasik complication. She sees a few dozen patients with ectasia; all of them show signs of depression, she said.

Lasik usually safe

Since the mid-1990s, numerous studies have shown that the surgery known as laser-assisted in-situ keratomileusis, or lasik, is safe and successful in most cases and has become more so with the introduction of new technology. Most of the 1.3 million Americans who undergo the surgery every year are happy with the results. The American Society of Cataract and Refractive Surgery, which represents about 9,000 ophthalmologists specializing in laser eye surgery, suggests that 2 percent to 3 percent of lasik patients experience complications.

Dr. Alan Carlson, a laser eye surgeon at the Duke Eye Center in Durham, built his career on correcting the vision of patients at high risk of complications. He said people at risk of depression or anxiety are generally not good candidates for lasik. He compared them to patients who become depressed after undergoing cosmetic surgery, another elective and medically unnecessary procedure.

“Their motivation and expectations may reflect something they’re missing in their life that they’re not telling you about,” he said.

But surgeons agree that lasik is unlike a face-lift or even most necessary surgery because it affects a process — seeing — that is essentially a mental function. The eyes focus light, but what a person actually sees depends on how the brain decodes an image. Neurological differences in decoding explain why dyslexics reverse letters and why alcohol consumption can produce double vision.

Although laser eye surgery has been around for years, little research has been done to explore how the ability to see affects how people feel and act. In 2006, the FDA began to look into lasik complications and quality-of-life issues and determined more research was needed. A task force that includes representatives of the National Eye Institute and the National Institutes of Health has since formed to design a large study that would be conducted by laser eye surgeons across the country.

Vision-mind connection

The FDA is also planning an open public meeting this spring to discuss experiences with lasik devices since their introduction to the U.S. market.

A few researchers have already looked at whether changes in vision can affect the mind. Scientists at the Emory Eye Center in Atlanta reviewed suicides among organ donors who had had laser eye surgery.

Preliminary results suggested the suicide rate might be four times as high among cornea donors who had had lasik as among cornea donors who had not. But the data were incomplete and the numbers could be significantly skewed, said Dr. Henry Edelhauser, the professor of ophthalmology who oversaw the Emory study. One of the participating eye banks failed to provide vital statistical data.

Research that Schallhorn did at the Navy Refractive Surgery Center suggests a relationship between satisfaction after lasik and certain personality traits among patients. Schallhorn declined to provide details. Like the results of the Emory suicide study, his research has not been published in peer-reviewed journals.

But some patients are unequivocal: Lasik complications drove them to contemplate suicide.In Cleveland, Tenn., Kim Hybarger, 44, a nurse, developed debilitating visual distortions after lasik surgery Dec. 21, 2006. She tried to walk into traffic, cut her throat and starve herself.

“I was filled with anger,” she said. “I felt so hopeless and helpless. I just wanted to die. The way I saw was so frightening.”

Her vision was blurry. The moon had six to eight overlapping copies, a distortion called ghosting. Bright lights erupted into irregular star bursts in the shape of chicken feet.

Hybarger compared her vision to looking through glass that is cracked and smeared with grease. She stopped driving, exercising, working and going to the grocery store. She couldn’t read a book or watch television.

Hybarger said she had never had problems with depression before her lasik surgery. Afterward she felt so bad, she said, she told her husband to “load a gun with a bullet and give it to me. I’m not going to live the rest of my life like this.”

Hybarger’s mental state didn’t improve until Ed Boshnick, a Miami optometrist, offered to fit her with special contact lenses. Sales of the special lenses have increased with the rising number of Americans who had lasik since 2000. The lenses can restore the cornea’s shape and correct visual distortions.

New lenses help

Boshnick is one of a handful of specialists who have had considerable success fitting the lenses. Hybarger is one of about 250 patients with complications from lasik who regularly see Boshnick. About half of them suffer symptoms of depression, Boshnick said.

The new lenses can clear up more than vision.

Hybarger left Miami remembering the moment she first looked through them.

“It was indescribable,” Hybarger said. “It was like the first time I smiled in a year.”

sabine.vollmer@newsobserver.com or (919) 829-8992
SOURCE:  http://www.newsobserver.com/150/story/920341.html

Millions of Americans have undergone laser eye surgery to correct bad vision, and along with the procedure’s popularity something else is coming into focus: its hazards.

Advertising stresses the surgery’s safety, and most procedures are successful. Tiger Woods, who relies on keen eyesight as the world’s best golfer, pitches it as a quick and painless way to restore sharp vision. Even the U.S. Air Force, long skeptical of the surgery, changed its policy in May to let people who had LASIK apply for pilot training.

But every year thousands of Americans who undergo LASIK are left with chronic pain, dryness of the eyes, distorted night vision and even blindness, according to Food and Drug Administration statistics.

LASIK — which stands for laser-assisted in-situ keratomileusis — uses lasers to cut and reshape the cornea. It can improve eyesight without complications, but equipment flaws, a surgeon’s error or a failure to screen out patients whose eyes are ill-suited for the treatment can cause the operation to go awry.

The American Society of Cataract and Refractive Surgery, which represents about 9,000 ophthalmologists specializing in laser eye surgery, estimates that only 2 percent to 3 percent of the more than 1 million LASIK surgeries each year are unsuccessful. But Food and Drug Administration records of clinical studies show that six months after the surgery, up to 28 percent of patients complained of eye dryness, up to 16 percent had blurry vision and up to 18 percent had difficulty driving at night.

The Triangle, home to two medical schools, is a hot spot for LASIK; 11 eye centers will perform LASIK on about 8,000 patients this year, according to market research.

One of the leaders is Duke Eye Center, whose LASIK surgeons are among the best-trained and best-equipped in the field.  But even surgery at Duke’s level has damaged a few patients’ eyes beyond repair.

One of those patients is Matthew Kotsovolos, 38, of Raleigh. He was the Duke Eye Center’s head of finances and received the surgery for free June 8, 2006. It gave him 20-20 vision but left him with intensely dry eyes and excruciating facial pain. He wakes up with sore eyes every morning, wears special goggles to preserve eye moisture and wonders when the pain in his face will kick in.

“I traded in my glasses for permanent head pain, eye pain and these things,” Kotsovolos said, pointing to the goggles.

Nine months after his surgery, Kotsovolos quit his job at the Duke Eye Center, took a 25 percent pay cut and started work as business manager in the Duke University Medical Center’s gastroenterology division. He is organizing a support group for LASIK patients with complications.

“It may help inform people that this is a surgery with real risks that are understated by LASIK surgeons,” Kotsovolos said.

Alan Carlson, head of the Duke Eye Center, said his experience with LASIK is that complications are rare. Carlson, who did not operate on Kotsovolos, said only a handful of the roughly 6,000 LASIK patients he has treated at Duke since 1996 ended up with problems. The eye center does very well in patient satisfaction surveys, he said.

But Carlson acknowledged that the procedure can cause serious complications.

“It’s imperfect surgery in an imperfect world,” he said.

How many LASIK patients develop post-surgery complications is obscured by a lack of regulation and reporting. Because health insurers don’t pay for LASIK, they generally don’t track complications. The FDA doesn’t require reports from doctors, and regulatory enforcement has been largely limited to recalling malfunctioning lasers.

Post-LASIK lenses

Evidence of problems is accumulating. Some of the strongest is the growing market for contact lenses designed for people who have undergone LASIK and still have vision problems, some seeing worse than before the surgery. One of the leading post-LASIK lens makers is MedLens Innovations, a Front Royal, Va., company founded in 2000.

Robert Breece, an optometrist and MedLens’ president, said his company provides hard contacts to more than 2,500 post-LASIK patients annually and business is increasing about 10 percent every year. Breece said his company serves more than 200 people per year who have been seriously disabled by the surgery.

“I don’t get to talk to happy LASIK patients,” he said.

By the end of the year, SynergEyes of Carlsbad, Calif., plans to bring to market the first line of contact lenses designed specially for laser eye surgery patients with complications who cannot tolerate hard lenses.

A trial version of the SynergEyes contact lenses have given Paula Cofer, 49, of Tampa, Fla., some relief from dry, itchy eyes and night vision so distorted that she sees up to eight moons.

The specially fitted contacts cost $300 every six months, Cofer said. Contact lenses solution, sterile saline solution, artificial tears and lenses rewetting drops run another $150 to $160 per month.

“Life was very simple then,” she said about the 30 years she wore glasses. “Now, it’s very complicated.”

Limitations of LASIK

Patients with complications are starting to fight back on the Internet and through support groups. Medical research in the past three years has come up with insights about LASIK worrisome enough that some eye surgeons have begun to ease away from the procedure.

“We’ve learned the limitations of LASIK,” said Dr. Stephen Pflugfelder, professor of ophthalmology at Baylor College of Medicine in Houston.

An expert in laser eye surgery for more than 15 years, Pflugfelder is increasingly falling back on an older, less invasive procedure known as photorefractive keratectomy, or PRK, which involves only the surface of the eye.

In the past three years, the number of LASIK procedures at Baylor has dropped from about 70 percent to about 50 percent of all laser eye surgeries.

At Duke, LASIK makes up about 80 percent of all laser eye surgeries. Carlson, head of the Duke Eye Center, is comfortable with that.

“Dry eye hasn’t been a big problem,” he said.

The university buys the most sophisticated lasers on the market, he said. Patients are screened for risk factors and informed of what they can and cannot expect from LASIK. A surgeon might even do the surgery on one eye at a time.

Those precautions did not prevent Lauranell Burch, a former Duke medical researcher, from suffering a serious complications after undergoing LASIK at the Duke Eye Center.

Burch 47, said that since the surgery March 31, 2004, her eyes sting and burn all the time, her eye tissue is wrinkled like a Ruffles potato chip and her night vision is distorted.

“[The damage] is noticeable and on the front of your mind all your waking hours,” Burch said. “There’s no escape.”

In the winter, she takes an anti-anxiety pill about 15 minutes before she drives home in the dark from her job in Research Triangle Park. She compares the distortions she sees at night, also known as star bursts, to explosions of light without a bang.

Burch cut short her follow-up treatment at Duke, became an avid patients’ advocate and started to take on LASIK surgeons on the Internet.

Risks of high volume

All LASIK surgeons make an effort to screen patients, and many turn away patients with obvious risk factors.

But LASIK is essentially a buyer-beware procedure.

In choosing a surgeon, patients are usually advised to go with doctors who perform the procedure most frequently. But with LASIK, that advice can be risky.

Dr. Christopher Fleming, a Cary ophthalmologist and former president of the N.C. Society of Eye Physicians and Surgeons, said patients should beware of LASIK surgeons who perform a high volume of operations.

Surgeons who do 10 or 15 LASIK operations a week tend to contract with optometrists who refer patients, Fleming said. In return, the optometrists, who are not medical doctors, screen the patients and do the follow-up care. Some also receive referral fees.

The emphasis on volume, Fleming said, can draw patients into surgery whose eyes are not suited to LASIK. Patients also end up getting follow-up care from optometrists instead of their surgeons.

Fleming performs no more than one or two dozen LASIK surgeries a year and personally screens patients and does the follow-up care. As a result, his patients rarely have complications, he said.

“When you’re high-volume and relinquish part of the care to non-physicians,” Fleming said, “you don’t have time to be thorough. That can lead to problems.”

What deters lawsuits

How many North Carolinians have problems after LASIK is not a public record. Patient complaints filed with the N.C. Medical Board are confidential, and the data are not organized by medical procedure.

Only a few complaints become lawsuits, said Bill Faison, a well-known medical malpractice lawyer in Durham who has represented one LASIK patient in court in the past three years.

What foils most attempts to sue for damages, Faison said, are the costs to mount a legal challenge. Also, carefully worded patient consent forms spell out the risks of the surgery and often require patients to first try to work out their differences with the LASIK center.

“Short of the [LASIK surgeon] being stupid, if it’s just a bad outcome, there’s nothing to recover,” Faison said.

The procedure is safe and effective for many, said Dr. Brad Randleman, a laser eye surgeon at Emory University in Atlanta who has done LASIK on about 1,000 patients over the past five years.

Post-surgical complications such as dry eyes and vision distortions often subside after a few weeks.

“I had nothing but a great experience,” said Jim Branch, 55, a Raleigh real estate developer who had LASIK at Duke about five years ago.

Medical research has found that cutting the cornea permanently weakens it. The severed nerves need years to recover and might misfire pain signals. But those findings have not been conclusively linked to lingering complications from LASIK, said Dr. William Bourne, an ophthalmology professor and LASIK surgeon at the Mayo Clinic in Rochester, Minn.

“I don’t think we’ve proven what it is,” Bourne said.

A better understanding of what causes the complications is essential to screen patients more effectively and eliminate those at risk, he said.

Kotsovolos said he was considered a good candidate for LASIK. His Duke LASIK surgeon blamed part of his problems on an eye inflammation unrelated to the procedure. Another eye specialist has since diagnosed Kotsovolos with a severe dysfunction of the glands lining the eyelids. The condition is considered a red flag when it is found during screening for LASIK.

Charles Hybarger, a building contractor who lives near Chattanooga, Tenn., changed his mind about LASIK after his wife, Kim, a 44-year-old trained nurse, had an unsuccessful procedure Dec. 21 and the complications triggered a deep depression.

Hybarger wonders whether his wife’s rheumatoid arthritis should have eliminated her from having LASIK. Laser eye surgery should not be done on patients with auto-immune diseases.

“I wouldn’t let any doctor cut on me unless it’s life or death,” Hybarger said. “I just wear my glasses and be happy with it.”

sabine.vollmer@newsobserver.com or (919) 829-8992
SOURCE:  www.newsobserver.com/front/story/721249-p3.html

Public documents recently uncovered by Brent Hanson show that the Sacramento District Attorney directed the Bureau of Family Support to place liens on all property owned by Glenn Hagele, for his refusal to pay court-ordered child support.  View a scanned copy of the order by the Sacramento District Attorney, at LasikMarketing.biz.

SOURCE:  USAEyes.us

Public documents recently uncovered by Brent Hanson show that the Glenn Hagele filed a bankruptcy petition for the amount of $431,000, with over 50 creditors.  View a scanned copy of the bankruptcy filing, at LasikMarketing.biz.

SOURCE:  USAEyes.us

Public documents recently uncovered by Brent Hanson show that the IRS and State of California placed liens on property owned by Glenn Hagele, for his failure to pay taxes.  View a scanned copy of the liens, at LasikMarketing.biz.

SOURCE:  USAEyes.us

The complete story is available at www.usaeyes.us

Judge Hoch chose his surgeon carefully when he decided in 1998 [apparently not] to undergo laser correction of his nearsightedness. Following the recommendation of his local optometrist, Judge Hoch made an appointment with Dr. Stephen Brint, a LASIK pioneer [all surgeons claim to be "pioneers"] and internationally preeminent ophthalmic surgeon. Dr. Brint was associated at the time with a chain of laser surgery clinics located throughout the country called The Laser Center, Inc. (TLC).

Using assembly-line-like procedures, TLC-employed optometrists oversaw initial testing procedures, pre-qualified patients for surgery, and then lined up surgical candidates upon whom Dr. Brint would fly in to operate. Surgery was performed on both of Judge Hoch's eyes on the same occasion.

By all accounts, Dr. Brint's surgical technique was flawless. By Dr. Brint's own candid admission, however, Judge Hoch never should have been operated on at all. The screening tests conducted by TLC and provided to Dr. Brint for review before surgery showed that Judge Hoch had a condition called keratoconus - irregularly shaped corneas - that disqualified him for LASIK surgery. Instead of improving Judge Hoch's vision, the surgery triggered a series of worsening vision problems that led to legal blindness in one eye that could only be improved - though not completely cured - by a corneal transplant. The need for at least one additional corneal transplant in the other eye is expected.

Attorneys Bill King and Jack Scarola filed suit on Judge Hoch's behalf against both TLC and Dr. Brint, who were separately insured and separately represented. Although Dr. Brint admitted for the first time at deposition that he had fallen below the generally accepted standard of care, TLC vigorously continued to contest liability, and both defendants challenged every element of Judge Hoch's damage claims. The defendants focused substantial attention on the fact that Judge Hoch had continued a very successful practice as a workers' compensation mediator and was earning more after his LASIK surgery than before.

Following more than three years of litigation involving some of the top LASIK and vision correction experts in the world, and with a lengthy trial scheduled to begin in just weeks, TLC agreed to pay $900,000 to settle the portion of the case directed against it. Trial preparation for the case against Dr. Brint continued until a separate negotiated settlement was reached with Dr. Brint's liability insurance carrier. The amount of the second settlement is confidential.

www.usaeyes.us/lawsuits/dr.-stephen-brint-sued-by-rand-hoch-for-medical-malpractice.html

CRSQA (Council for Refractive Quality Assurance) is a referral service for LASIK surgeons, operated by Glenn Hagele out of his home.  Despite its pretentious name, CRSQA is just a cynical marketing ploy that "certifies" refractive surgeons willing to fork over $7,000 in the first year and $5,000/year thereafter.  In exchange, Glenn Hagele provides these surgeons with a  bogus seal of approval on his USAEYES.org web site to promote their practices.  Don't be fooled by Glenn Hagele's advertising claims - CRSQA's quality "standards" are actually below industry standards.

Out of 17,000 ophthalmologists in the US, about 30-40 pay Glenn Hagele to market their practices.  It is somewhat difficult to tell exactly what ophthalmologists are members of CRSQA at any one time, as Glenn Hagele has designed his web site in such a manner to implicitly suggest that 17,000 ophthalmologists are members. 

The mission of USAEYES.us is to:

1. Expose the false advertising by Glenn Hagle and CRSQA on his USAEYES.org web site.
2. Identify the surgeons who have purchased advertising services from Glenn Hagele.
3. Identify surgeons who are not members of CRSQA, but receive public pronouncements of support when criticized by patients who have been injured by laser eye surgery.
4. Provide information on malpractice lawsuits filed against surgeons who are recommended or supported by Glenn Hagele.
5. Provide legal information to those patients who wish to file medical malpractice lawsuits against surgeons who are supported or recommended by Glenn Hagele.

The fantasy that Burch calls "The LASIK Report", fully attributed to her, is being distributed to all doctors cited, Burch's employer... 

Contrary to Glenn Hagele's statements that The Lasik Report was "attributable" to Dr. Lauranell Burch,  the document was published anonymously.  John Ciccone presented a clumsily altered version of the document designed to mislead others into showing that Dr. Lauranell Burch authored the document as a representative of a government agency, when in fact the document was published anonymously by a private citizen.

Glenn Hagele previously threatened to publish the social security number of Dr. Lauranell Burch in addition to the social security number of other individuals.  This action follows a pattern of similar behavior in which Glenn Hagele began harassing Paula Cofer at her home and place of employment.

After reviewing the original version of The Lasik Report, ASCRS board members issued the following comments.

In discussing Glenn Hagele's harassment of patients, Dr. Richard Lindstrom provided the following advice to ASCRS' Board of Directors.

I believe this has become a no win tar baby.  When founded by Dan Durrie the charter of this group (CRSQA) seemed reasonable. Now it has deteriorated into a Bagdad (sic), Iraq type scene where there will be no  winners, just all losers. I suggest we stay away. It has become a lose/lose and is now very personalized. Glenn  seems to see himself as a white night crusading for Laski (sic) and his dissatisfied patient enemies wish to destroy the operation entirely.  We cannot win by getting involved. There are not at this time reasonable people on either side.  What you read here is just a paragraph in a thick book of similar accusations and counteraccusations including active litigation.  Sandy Keller is not ASCRS friend, nor at the moment is Glen Hagele. None of this is good for the field or ASCRS.  Stay as far away as you can.

March 2, 2006

VIA UPS OVERNIGHT DELIVERY

Brent Hanson
11 Wickersham Drive
Durham, NC 27713

Re:    Defamation of Glenn Hagele

Dear Mr. Hanson:

Glenn Hagele has retained our law firm in connection with written statements you have published or caused to be published either through public Internet forums, Internet websites you control, email, and/or conventional mail.  Demand is herewith made that you stop publishing the false statements concerning our client and that you take prompt corrective action, absent which we shall have no choice but to seek appropriate legal redress.

You have made written statements of fact, rather than opinion, that appear to violate Mr. Hagele's constitutional rights, place him in a false light, tend to injure and in fact do cause injury to our client's occupation and character, and/or expose him to hatred, contempt, ridicule or shame.  Moreover, we believe your written statements constitute defamation per se - all of which have caused our client substantial injury and interfered with his ability to conduct his business.

Mr. Hagele herewith demands of you the following: 

1. Immediately remove or cause to be removed all publicly accessible Internet newsgroup, bulletin board, or chat room statements about him, his employer, and/or his business associates, which may be decided by the court as defamatory and refrain from publishing or republishing any and all future statements that may be considered defamatory;
    

2. Immediately remove or cause to be removed those portions of all publicly accessible Internet web pages you control that include statements about him, his employer, and/or his business associates, which may be decided by the court as defamatory and refrain from publishing or republishing any and all future statements that may be considered defamatory;
    

3. Immediately privately retract all statements about him, his employer, and/or his business associates that may be decided by the court as defamatory and were distributed via email, conventional mail, or any other private means and refrain from publishing or republishing any and all future statements that may be considered defamatory.

This is your opportunity to resolve this matter without legal expense and exposure to liability and damages.  Mr. Hagele retains his right to all legal means to seek redress of losses caused by your prior acts, however, removal of your statements will mitigate damage already caused.

Accordingly, if the offending written statements are not removed or retracted within 72 hours, further legal action will be taken.

If you have any questions regarding the above referenced matters, please do not hesitate to call us.

Very truly yours,
James A. Clinchard

cc:    Glenn Hagele

Here are Glenn Hagele's threats which he published at the alt.lasik-eyes newsgroup

February 23, 2006

As for who admits to ownership of LasikDisaster.com and when, that will be determined in a different forum. Considering the liabilities there, I'm not surprised that Keller would attempt to distance herself. Who is responsible for the authorship of the defamation at LasikDisaster.com is another matter altogether. Again, that is something for a different forum.

So now we see Keller attempting to absolve herself of all responsibility for the website she created, which puts the consequences squarely on Paula Cofer. Keller, are you saying Cofer is solely responsible for what is on LasikDisaster.com? Did she accept all liability for the website from you? On what date did this momentous event occur, Keller? Did she specifically accept the legal liability for the defamation you created, but she perpetuates? That will be an interesting document to see.

If Keller wants to say only Cofer is making money off of Lasik ads at LasikDisaster.com and only Cofer is responsible for the content at LasikDisaster.com, then that's fine with me. Let's see you point the finger at your accomplic-...er...buddy Cofer.

You could tell us all right here and now. Why wait for the subpoena? You could tell us when (if) you transferred ownership and responsibility of LasikDisaster.com to someone else, who that someone else is, and when the ads started.

Yes, I can litigate and attempt to have the whole thing brought down, and that is in process.

Wrong again, Keller. Investigators in five states have been doing the bulk of the work, but I do what I can. My attorneys are quite energetic, outrageously over-priced (but worth every cent), and "as if" Keller could be intimidated with mere words in a newsgroup. I suspect much more would be required.

Filing Date: 01/24/2006
Case Type: Med Malpractice (Drs & Surgeons) (General Jurisdiction)
Status: Pending

Future Hearings

01/24/2007 at 08:30 am in department WEM at 1725 Main Street, Santa Monica, CA 90401
Motion - Summary Judgment ((2) MOTIONS FOR SUMMARY JUDGMENT)

02/20/2007 at 08:30 am in department WEM at 1725 Main Street, Santa Monica, CA 90401
Final Status Conference (JURY TRIAL - 5-7 DAYS - 2/26/07)

02/26/2007 at 09:30 am in department WEM at 1725 Main Street, Santa Monica, CA 90401
Jury Trial (5-7 DAYS)

Parties

ALCON LABORATORIES INC. - Defendant

ALCON MANUFACTURING LTD. - Defendant

CASTER EYE CENTER - Defendant

CASTER M.D. ANDREW I. - Defendant

HERZOG IAN LAW OFFICES OF - Attorney for Plaintiff

LEWIS BRISBOIS BISGAARD & SMITH LLP - Attorney for Defendant

MARICH ALLISON - Plaintiff

MORGAN LEWIS&BOCKIUS - Attorney for Defendant

SHOOK HARDY & BACON L.L.P. - Former Attorney for Defendant

Documents Filed (Filing dates listed in descending order)

11/13/2006 Motion for Summary Judgment
Filed by Attorney for Defendant

11/13/2006 Proof of Service
Filed by Attorney for Defendant

11/13/2006 Separate Statement of Und. Facts
Filed by Attorney for Defendant

11/13/2006 Memo points & authorities
Filed by Attorney for Defendant

11/13/2006 Declaration (OF MEGAN K. ROSICHAN )
Filed by Attorney for Defendant

11/09/2006 Motion for Summary Judgment
Filed by Attorney for Defendant

11/09/2006 Separate Statement of Und. Facts
Filed by Attorney for Defendant

10/24/2006 Ex-Parte Application (FOR ORDER GRANTING DEFENDANTS A COMMISSION TO TAKE DISCOVERY FROM AN OUT-OF-STATE INDIVIDUAL PURSU- ANT TO CALIFORNIA CODE OF CIVIL PROCEDURE SECTION 2026(c) & (f) )
Filed by Attorney for Defendant

10/24/2006 Declaration (OF MEGAN K. ROSICHAN IN SUPPORT OF DEFENDANTS ALCON MANUFACTURING, LTD AND ALCON LABORATORIES, INC.'S EX PARTE APPLICATION FOR ORDER GRANTING DEFENDANTS COMMISSIONS TO TAKE DISCOVERY FROM OUT-OF-STATE)
Filed by Attorney for Defendant

10/24/2006 Memo points & authorities
Filed by Attorney for Defendant

10/24/2006 Order (GRANTING ISSUANCE OF A COMMISSION TO TAKE DISCOVERY FROM AN OUT-OF- STATE INDIVIDUAL PURSUANT TO CALIFORNIA CODE OF CIVIL PROCEDURE SECTION 2026(C)&(F) )
Filed by Attorney for Defendant

08/29/2006 Ex-Parte Application (FOR ORDER GRANTING DEFENDANTS COMMISSIONS TO TAKE DISCOVERY FROM OUT-OF-STATE INDIVIDUALS PURSUANT TO CALIFORNIA CODE OF CIVIL PROCEDURE 2026(c) & (f) )
Filed by Attorney for Defendant

08/29/2006 Declaration (OF MEGAN K. ROSICHAN IN SUPPORT OF DEFENDANTS ALCON MANUFACTURING, LTD AND ALCON LABORATORIES, INC.S EX PARTE APPLICATION FOR ORDER GRANTING DEFENDANTS COMMISSIONS TO TAKE DISCOVERY FROM OUT-OF-STATE)
Filed by Attorney for Defendant

08/29/2006 Memo points & authorities
Filed by Attorney for Defendant

07/20/2006 Substitution of Attorney
Filed by Attorney for Defendant

05/24/2006 Order (RE: TRIAL SETTING ORDER FOR JURY TRIAL )
Filed by Court

05/10/2006 Notice (OF CONTINUANCE OF CMC )
Filed by Plaintiff & Plaintiff In Pro Per

05/10/2006 Statement-Case Management
Filed by Plaintiff & Plaintiff In Pro Per

05/10/2006 Substitution of Attorney
Filed by Attorney for Plaintiff

05/09/2006 Statement-Case Management
Filed by Attorney for Defendant

05/08/2006 Statement-Case Management
Filed by Attorney for Defendant

05/08/2006 Answer
Filed by Attorney for Defendant

05/04/2006 Answer to Complaint Filed
Filed by Attorney for Defendant

04/11/2006 Notice (OF CONTINUANCE OF OSC AND CMC )
Filed by Plaintiff & Plaintiff In Pro Per

04/11/2006 Proof of Service (RE CASTER EYE CENTER )
Filed by Plaintiff & Plaintiff In Pro Per

04/11/2006 Proof of Service (RE ALCON MANUFACTURING, LTD )
Filed by Plaintiff & Plaintiff In Pro Per

04/11/2006 Proof of Service (RE ALCON LAABORATORIES, INC )
Filed by Plaintiff & Plaintiff In Pro Per

04/11/2006 Proof of Service (RE ANDREW I. CASTER, M.D. )
Filed by Plaintiff & Plaintiff In Pro Per

03/20/2006 Notice-Case Reassignment and Order
Filed by Clerk

01/24/2006 Complaint Filed

www.usaeyes.us/lawsuits/dr.-andrew-caster-sued-by-allison-marich-for-medical-malpractice.html

The Alcon LADARVision excimer laser does not appear to have any inherent design problems and hundreds of thousands of patients have had satisfactory outcomes. In fact, even those who alledged a problem acknowledged that no patients were harmed.

However, the FDA has described serious problems with the laser involving "Laser not firing", "Translator malfunction", "Loss of tracking", and "Not able to track" as documented in a warning letter to Alcon. 

WARNING LETTER

FLA-05-27

April 15, 2005

Mr. Gary A . Woodrell
Vice President
Refractive Manufacturing Operations
Alcon Laboratories, Inc.
2501 Discovery Drive
Orlando, Florida 32826

Dear Mr. Woodrell :

During an inspection of your establishment located in Orlando, Florida on January 10 - 18, 2005, our Investigator determined that your firm manufactures the LADARVision 4000 Excimer Laser System. An excimer laser is a device as defined by Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), [21 U.S.C. 321(h)].

The above-stated inspection revealed that this device is adulterated under section 501(h) of the Act, in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation are not in conformance with the Current Good Manufacturing Practice (CGMP) requirements for medical devices which are set forth in the Quality System regulation, as specified in Title 21, Code of Federal Regulations (CFR), Part 820. Significant deviations include, but are not limited to, the following:

1. Failure to review and evaluate all complaints to determine whether an investigation is necessary. When no investigation is made, the manufacturer shall maintain a record that includes the reason no investigation was made and the name of the individual responsible for the decision not to investigate as required by 21 CFR 820.198(b). (FDA 483, Item #1).

Data downloaded from LADARVision systems currently in use in the U.S. showed significant differences in the retreatment requirements between patients treated prior to 15 minutes after calibration of the device as opposed to patients who were treated after 15 minutes following calibration of the device. Another table was provided that used the points of < 30 minutes from calibration to treatment and > 30 minutes or more from calibration to treatment.

A patient whose surgical procedure is initiated after 30 minutes has a 30% greater risk of retreatment than does the patient whose treatment commences prior to 30 minutes after calibration. Beam drift occurs if too much time passes between calibration and treatment, with possible translation or rotation of the beam.

Your response to this data has been inadequate. There is a note to a warning to the device user manual, which states, "WARNING: System calibration must be done between patients and within 15 minutes of surgery, failure to perform calibration in the time frame indicated may result in improper orientation of the ablation. " However, there was no reason provided to explain the use of these times. Moreover, the note to warning is not by itself sufficient to address the seriousness of this problem . (FDA 483, Item #1)

2. Failure to review, evaluate, and investigate any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications, unless such investigation has already been performed for a similar complaint and another investigation is necessary as required by 21 CFR 820.198(c). Complaints received from January 1, 2002, through January 10, 2005, revealed the most common complaint codes as follows:

• Class code - 801: Laser not firing,

• Class code T 833: Translator malfunction,

• Class code - 802A: Loss of tracking, and

• Class code - 802B: Not able to track

Complaint records associated with these complaint class codes are not adequately reviewed, evaluated, and investigated to determine the root-cause of the system and/or sub-assembly component malfunction (FDA 483, Item #2).

Specific complaints reviewed during the inspection revealed the following:

a . Complaint Record RS030392 received on April 14, 2003, involving the LADARVision® 4000 Beta, lot number L4B1023S references the laser stopped firing during surgery at 92% complete. The Field Service Engineer (FSE) found arcing in the laser chassis assembly. The FSE adjusted components to prevent future arcing. The complaint record does not document and confirm that an investigation was conducted to determine the root cause of the reported problem. The record also fails to document the justification for not conducting an investigation and is not signed and dated by responsible personnel.

b. Complaint Record RS041106 received on August 23, 2004, involving LADARVision® 4000 Beta, lot number L4B1023S references the laser not firing. An FSE replaced the laser control electronics that failed. The replaced component was evaluated and verified the failure was caused by a broken connector. The record does not document and confirm that an investigation was conducted to determine the root cause of the broken connector. The record also fails to document the justification for not conducting an investigation and is not signed and dated by responsible personnel.

c. Complaint Record RS041047 received on August 11, 2004, involving a refurbished LADARVision® 4000 Beta, lot number L4B1090S referencing noise from the laser with a system failed error message. A similar complaint, RS030392 referenced a malfunctioning translator, which was replaced because of faulty/defective bearings. The complaint was classified as complaint class 823- Noise Coming from system. The complaint was more appropriately determined a translator malfunction, which is complaint class 833. The malfunction causes the laser to stop operating or firing resulting in surgery being terminated, causing under correction, which is not considered by your firm to be an injury.

d. Complaint Record RS030539 received on May 16, 2003, involving LADARVision® 4000 Beta, lot number L4B1022S referencing loss of tracking during surgery. Surgery was stopped at 57% complete. The FSE balanced the infrared pulse and changed the DSP gains. The record does not document an investigation that was conducted to determine the root-cause of the report to conduct an investigation into the reported malfunction.

e. Complaint Record RS031262 received on November 14, 2003, involving LADARVision® 4000 Beta, lot number L4B1022S references a laser unable to track. The FSE confirmed the failure mode and replaced the zoom motor. The Manufacturing Engineer (ME) confirmed that the motor performed erratically when operating under a torque and will not reverse direction when prompted by software. A similar complaint FS030539 (noted above) does not document that an investigation was conducted to determine the root cause for the zoom motor failure or the justification for not conducting an investigation into the malfunction.

3. Failure to promptly review, evaluate, and investigate any complaint that represents an event which must be reported to FDA under 21 CFR part 803 by a designated individual(s) and shall be maintained in a separate portion of the complaint files otherwise clearly identified as required by 21 CFR 820.198(d) and 803..50(b)(2).. (FDA 483, Item #3). Complaint .Record RS041447 received on November 5, 2004, (MDR 1061857-2004-00011) involving the LADARVision® 4000, lot number L4N1636S referenced the report of a poor clinical outcome. The primary custom-cornea, lasik procedure conducted on June 4, 2004, resulted in a two line loss of Best Corrected Visual Acuity (BCVA), 20/20 at pre-op and 20/30 at the four month post-op visit. A retreatment was conducted on October 29, 2004, resulting in an additional one line loss of BCVA, which was 20/30 at four months after post-op and 20/40 at one week after the retreatment post-op visit. No review, evaluation, and investigation were conducted of the primary custom-cornea lasik procedure on June 4, 2004. The retreatment procedure was reviewed, evaluated, and investigated, which is not covered under the system's labeling including the collection of data such as Operative Summary, LadarWave printouts, and Operative Reports. The complaint was closed December 13, 2004. No review, evaluation or investigation was conducted of the primary custom-cornea, lasik procedure which occurred on June 4, 2004.

4. Failure to establish and maintain procedures that define the responsibility for review and the authority for the disposition of nonconforming product as required by 21 CFR 820.90(b)(1). (FDA 483, Item #4). Your own procedures, specifically, SOP 7501-00.38, Field Returns, and SOP 7003-0909, Evaluation of Non-Conforming Parts Returned from Field Service, are not followed:

a. Complaint Record RS040448 - Per the referenced SOPs all parts replaced in the field are to be returned for evaluation. An evaluation of malfunctioning translators was not conducted as required and the service activity was considered routine maintenance instead of being assessed as a complaint.

b. Complaint Record RS040031 - Per the referenced SOPs gas filters were not returned for evaluation and an evaluation was not performed. This report was evaluated by Product Safety (PS) and classified as a "Malfunction". Personnel experienced headache, dry tight throat, and nausea resulting in an emergency room (ER) visit.

c. Complaint Record RS031155 - A FSE found a lead washer was unevenly crimped, which he replaced. The part was not returned and an evaluation was not performed. A MDR was evaluated by your PS team and classified as "Other" without explanation. Personnel experienced vomiting and nausea resulting in an ER visit.

The above-stated inspection also revealed that your device is misbranded under section 502(t)(2) of the Act, in that your firm failed or refused to furnish any material or information required by or under section 519 respecting the device. Specifically, your firm failed to report within 30 days whenever the manufacturer receives or otherwise becomes aware of information, from any sources, that reasonably suggests that a device marketed by the manufacturer has caused or contributed to a death or serious injury, as required by 21 CFR 803.50(a)(1).

The following complaints referencing serious injuries where not submitted within 30 days to FDA as required:

a. Complaint Record RS041329
b. Complaint Record RS030632

Your firm also failed to investigate adverse event reports and to evaluate the cause of the reported event as required by 21 CFR 803.50(b)(2). The following adverse event reports have not been adequately investigated as required:

a. Complaint Record RS030392
b. Complaint Record RS041106
c. Complaint Record RS041047
d. Complaint Record RS031262
e. Complaint Record RS030355
f.. Complaint Record RS031146
g. Complaint Record RS030632
h. Complaint Record RS031257

This letter is not intended to be an all-inclusive list of violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.

We have reviewed your response, dated February 3, 2005. We acknowledge that you have proposed to improve your complaint handling procedure. We would appreciate receiving the periodic reports that you have promised. Nevertheless, your response to the violations discussed above is inadequate because our review of the data shows that reviews, evaluations, and corrective actions were not fully assessed. Also your own procedures were not followed and misinterpretations were made as to the status of complaints that were reported and the conclusions that were drawn, which affected the corrective actions that were required. You should address each and every observation when responding to this letter. Your response has been made part of the Florida District file.

Additionally, no premarket submissions for Class III devices to which QS regulation deficiencies are reasonably related will be cleared until the violations have been corrected. Also, no requests for Certificates to Foreign Governments will be approved until the violations related to the subject devices have been corrected. You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil penalties.

Please notify this office in writing within fifteen (15) working days of receipt of this letter, of any steps that you are still in the process of taking to correct the noted violations, including (1) the time frames within which the corrections will be completed, (2) any documentation indicating the corrections have been achieved, and (3) an explanation of each step being taken to identify and make corrections to any underlying systems problems necessary to assure that similar violations will not recur.

Your response should be sent to Timothy J. Couzins, Compliance Officer, Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, Florida 32751, (407) 475-4728.

Sincerely,

/S/

Emma R . Singleton
Director, Florida District

Ron Link founded Surgical Eyes in the late 1990's, ostensibly to help patients of failed refractive surgeries.  Surgical Eyes ceased to exist in October 2004 after the entire board resigned under pressure from Ron Link.  The Surgical Eyes bulletin board is now owned by the Vision Surgery Rehab Network, which is managed by Dr. David Hartzok and Barbara Berney.

Examples of Ron Link's postings:  1 2 3 4 5 6 7 8 9

Board member Andrew Robbins says Dr. Vikas Jain of Newark became a "predator," repeatedly mistreating patients.  Robbins says Jain's misdeeds included removing a cataract from a woman's blind eye, operating on patients who shouldn't have received LASIK including one who could see just fine, and using his operating equipment on the wrong settings.

The state will inform the national Federation of State of Medical Boards of its action, in hopes of preventing Jain from going elsewhere to practice.

Jain did not appear at Wednesday's hearing.  He can appeal to the Franklin County Common Pleas Court.

Source:  www.ohionewsnow.com/global/story.asp?s=4100431&ClientType=Printable

From: "Matt Ryan" <mryan@ceatus.com>
To: <mvanasek@kremer-laser.com>
Sent: Thursday, November 03, 2005 4:23 PM
Attach: ceatus_invoice_1187_Kremer.doc
Subject: Mary Guccione - AllAboutVision

Ceatus Marketing Inc. Invoice Number: 1187

We thank you for your business.

Ceatus Marketing Inc.
7580 Fay Ave., Suite 305
La Jolla, CA 92037
Phone: 858 454 5505
FAX: 858 454 5668

A lawyer's medical malpractice suit against a doctor who performs LASIK vision correction surgery was postponed yesterday after the plaintiff successfully argued that the defense improperly struck black jurors from the panel.

Represented by his law partner Jay D. Miller, George Psoras Jr. alleges he went blind in one eye after undergoing LASIK. Miller said the case against Dr. Anthony Kameen will be one of the first LASIK cases to go to trial in Maryland.

But it will have to wait. After jury selection produced an all-white panel, Miller challenged the process based on the Supreme Court's 1986 decision in Batson v. Kentucky, pointing out that the plaintiff's only expert witness is black.

After conferring with some of his colleagues, Baltimore County Circuit Court Judge Thomas J. Bollinger Sr. agreed to dismiss the jury and start over another day.  Defense attorney Neal Brown initially offered to swap a black alternate juror for the white foreman, but withdrew the offer after a brief recess.

No new trial date has been set.

Source:  www.mddailyrecord.com/pub/5_401_law/legalnews/172967-1.html

CHICAGO, Oct. 14 /PRNewswire/ -- Nearly 1 in 3 Americans have complained of under or over correction in one or both eyes, loss of quality of vision, vision fluctuations and poor vision in dark conditions, after undergoing Lasik surgery.

The survey conducted by Synovate and commissioned by NeuroVision Pte Ltd, also found that of all Americans who experience these conditions, those in the South and the mid-West, like Chicago, are more likely to have a second Lasik operation, compared with other regions.

"As Lasik is an invasive surgery performed on a very delicate part of the eye, potential problems may arise as a result of the operation," said Prof. Donald Tan, Director, Singapore Eye Research Institute, Deputy Director Singapore National Eye Centre. "Lasik has been an invaluable tool in vision correction, reducing refraction in patients by a significant percentage but it is not without its drawbacks."

1 in 3 respondents who encountered post-Lasik problems still wear their glasses or contacts and 1 in 7 of all respondents underwent a second Lasik operation. 

"In the past, there were few options to rectify unsatisfactory Lasik results. But now with the revolutionary NeuroVision treatment, patients can attain the sharp, crisp vision they desire," said Alain Leneveu, CEO, NeuroVision Pte. Ltd. "NeuroVision understands the intricacies of Lasik and is a complementary treatment to the surgery."

According to the survey, women are nearly three times more likely than men to undergo Lasik but men were more likely to complain and are twice as likely to be disappointed with their Lasik results complaining of over or under correction and poor night vision. 

"New data from NeuroVision, collated from over 300 international patients, has shown that post-Lasik patients, who have undergone NeuroVision, experienced a 2.6 lines improvement on the EDTRS chart and had a significant 100% enhancement in contrast sensitivity, moving their vision from the abnormal range to normal," said Prof. Donald Tan. "In total, 42% of both post-Lasik and low myopia patients improved by three lines or more on the EDTRS chart, with very minimal refraction changes."

NeuroVision is based on twenty years of scientific and clinical research, and is the world's first no surgery, no medication, no risk, vision treatment for low myopia, amblyo