April 20, 2010

FDA Review: 1 of 5 LASIK Patients Suffer Serious Complications

After researching all of the publicly accessible FDA documentation and a large amount of non-FDA literature, including peer-reviewed journals, correspondence between informed parties, and federal court documents, it is my carefully considered opinion that these lasers and associated hardware were respectively PMA-approved and 510(k)-cleared by FDA with egregiously insufficient evidence of their long-term safety and effectiveness for the LASIK indication.
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Posted by Admin at 01:44 AM

February 12, 2010

Dr. Gerald Horn Charged with Inside Trading by the SEC

By Hemma Ramrattan on February 12, 2010, 1:56 pm The SEC has charged ophthalmologist Gerald Horn with insider trading in the options of LCA-Vision Inc., a provider of laser eye surgery. Horn (pictured), the medical director of LCA’s Schaumburg, Illinois facility, reportedly faces civil charges over his purchases of options on the shares of LCA by which he made a profit of about $870,000. By exercising stock option grants and immediately selling this stock on the basis of nonpublic information,...
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Posted by Admin at 06:32 PM

October 15, 2009

U.S. Warns LASIK Clinics Over Failure to Report Side Effects

By Susan Heavey WASHINGTON (Reuters) - More than a dozen LASIK eye centers have poor systems in place to report any side effects in patients who have undergone the vision correction surgery, U.S. health regulators said on Thursday. There were no problems found with the laser devices used in the procedure, but U.S. Food and Drug Administration inspectors found problems with side-effect reporting systems at 17 LASIK vision correction centers. Warning letters were sent to the clinics, including some TLC...
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Posted by Admin at 02:56 PM

October 09, 2009

Dr. Thomas Tooma Violates FDA Safety Protocols (again)

  Laser Eye Care of California 10/09/09     Department of Health and Human Services Public Health Service Food and Drug Administration   10903 New Hampshire Avenue Silver Spring, MD 20993 OCT 09 2009 WARNING LETTER VIA FEDERAL EXPRESS Dr. Tom Tooma Owner Laser Eye Care of California 16255 Ventura Blvd. Suite 100 Encino, California 91436 Dear Dr. Tooma: During an inspection of your facility located in Encino, California on June 11, 2009, an investigator from the United States Food...
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Posted by Admin at 01:29 PM

May 22, 2009

FDA: LASIK Ads Must Warn Consumers of Risks

By Susan Heavey WASHINGTON (Reuters) - Doctors, clinics and others promoting corrective eye surgery known as LASIK need to make sure their advertisements tell consumers about possible risks, U.S. regulators said in a letter released on Friday. The Food and Drug Administration, which has been investigating patient complaints over the procedure, told healthcare providers that commercials and other promotions that do not convey necessary warnings, side-effects and other precautions are deceptive. "Advertising and promotional materials for FDA-approved lasers used during...
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Posted by Admin at 04:23 PM

November 14, 2008

Restraining Orders Issued Against Valley Eye Center

Las Vegas Now Eyewitness News A judge has just signed an order to stop the practice of medicine at the Valley Eye Center. The Channel 8 I-Team was the first to expose allegations of medical malpractice at the Lasik center where people say their sight was ruined. A judge approved a petition from the state medical board seeking temporary restraining orders and injunctions against the clinic. When the I-Team first examined Valley Eye back in May, we learned the state...
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Posted by Admin at 01:25 PM

October 31, 2008

Contact 13 Investigation Part II: Valley Eye Center and Vikas Jain

Contact 13 Investigation Part II: Valley Eye Center Lasik is one of the most popular elective surgeries in the world, it is supposed to allow you to trade in your glasses or contacts for near-perfect vision. Some say one local eye center is putting profits above patient care. Contact 13's Darcy Spears has been investigating this case for three months. "I wish I never got it," said Joanne Olimpo.  "The pain that I felt was excruciating," said Brandon Nybakken. The men and...
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Posted by Admin at 02:52 PM

October 29, 2008

Valley Eye Center and Vikas Jain Investigated by the State of Nevada

I-Team: Lasik Company Investigated by State Colleen McCarty, Investigative Reporter Jain lost his medical license in 2005 for harming more than 20 patients in the state of Ohio. There is an update on an I-Team investigation of a local Lasik clinic. State authorities say they're nearing the end of their review of the Valley Eye Center. I-Team Reporter Colleen McCarty first broke the story of alleged malpractice at the clinic. The State Attorney General's Office tells the I-Team it plans...
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Posted by Admin at 01:39 PM

November 11, 2005

Dr. Vikas Jain Loses Medical License

For the first time, the state Medical Board has punished a laser eye surgeon, stripping a central Ohio doctor of his license. 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...
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Posted by Admin at 09:35 AM

August 17, 2005

Complaint Filed Against Dr. Nicholas Caro with the Illinois Department of Professional Regulation

August 17th, 2005 Attn: Investigator Joe Annerino (Medical Enforcement) Illinios Department of Professional Regulation James R. Thompson Center 100 West Randolph, Suite#9-300 Chicago, Illinios 60601 w: 312-814-4526 F: 312-814-3145 Thank you for your reply to my initial complaint #200504961 against St. George Corrective Vision Center/Dr. Nick Caro: I do hope that this complaint issued by me is fully scrutinized. I also feel that if the attention to detail is given, many other findings will be revealed about this practicing doctor,...
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Posted by Admin at 08:15 AM

April 23, 2005

Dr. David Kleiman and Dr. Anthony Evangelista Fined by Texas State Board of Medical Examiners

State fines two eye doctors $ 25,000 each for unsubstantiated ads Maria M. Perotin Fort Worth Star Telegram Two ophthalmologists at an Arlington eye-care center have been fined $ 25,000 apiece for running advertisements that couldn't be substantiated. The Texas State Board of Medical Examiners reprimanded David Kleiman and Anthony Evangelista for ads published in various Dallas-Fort Worth newspapers. The ads for the Kleiman-Evangelista Eye Center contained statements such as "nearly three out of four patients are seeing better than...
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Posted by Admin at 03:17 PM

April 07, 2005

Lasek Surgery Disqualifies Israeli Pilots from Training Program

If you are one of many who underwent Lasek laser surgery for the removal of eyeglasses, perhaps in the hope of becoming eligible to apply for the Air Force's pilot training program, you may as well begin looking for an alternative military career. The IDF's weekly BaMahane magazine reported that people who underwent Lasek surgery are not eligible to apply for the pilot training program under regulations established by the air force's medical board. Those who wear eyeglasses or had...
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Posted by Admin at 05:45 PM

February 28, 2005

Dr. Herbert Nevyas and Dr. Anita Nevyas Accused of Submitting Fraudulent Reports to the FDA

Nevyas, while operating under and IDE for the Nevyas laser, failed to report various complications or adverse events to the FDA. Data from Nevyas simply cannot be trusted, and now Nevyas data has helped Intacs get on the market. The potential consequences could be severe.
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Posted by Admin at 02:42 PM

December 04, 2003

Dr. Anita Nevyas Target of FDA Criminal Complaint

I now call for an investigation by the Office of Criminal Investigation, for action which would: 1) Terminate all IDEs and stop Nevyas from performing LASIK. 2) Fine and otherwise sanction Nevyas for past improprieties. It is my sincere belief that only the FDA, or an equivalent governmental agency with power to investigate criminal behavior can properly evaluate and understand what these improprieties are. The civil justice system is not adequate to the task.
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Posted by Admin at 07:06 PM

November 18, 2003

Pennsylvania Department of Health Investigates "Drive-By" Lasik Surgeries

Groups Worried About Lasik Trucks Pittsburgh Post-Gazette Anita Srikameswaran Two medical organizations say the Pennsylvania Department of Health should be keeping an eye on surgical suites in trucks that provide laser vision correction in parking lots and other off-street locations. Current regulations for surgical centers need to be updated to account for mobile facilities, said Dr. Michael J. Azar, president of the Pennsylvania Academy of Ophthalmology. "When the regulations were written, the state had no way of knowing that someday...
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Posted by Admin at 06:04 PM

November 10, 2003

Lasik Vision Institute Faces Criminal Investigation by Florida Attorney General

Doctor blows the whistle on Lasik eye surgery chain www.abcactionnews.com/stories/2003/11/031110lasik.shtml TAMPA - The Lasik Vision Institute, also known as LVI, offers rock-bottom rates on laser eye surgery. But when some patients came forward with serious medical problems, ABC Action News began investigating. What senior investigator Mike Mason found will open your eyes like no other investigation he's done. Judy Sanders had Lasik surgery last year at the Lasik Vision Institute on Fowler Avenue in Tampa. "I said, 'What's that smell?'...
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Posted by Admin at 09:54 AM

November 05, 2003

Louisiana Ophthalmologist Fined $1.1 Million by FDA

A Lafayette, La., ophthalmologist and eye care center he owns have agreed to pay the federal government a total of $1.1 million in civil money penalties for violating federal laws related to the conduct of clinical studies. The violations involved studies of a laser system built by the ophthalmologist for LASIK treatment of nearsightedness. In a settlement agreement signed today with the Food and Drug Administration (FDA), Leon C. LaHaye, M.D., will pay $150,000 and his LaHaye Center for...
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Posted by Admin at 09:43 PM

August 17, 2003

British Goverment Declares War on "Laser Center Cowboys"

By Keith Gladdis News Group Newspapers LTD The News of the World LASER eye clinics face tough new regulations to protect patients from rogue medics. More than 100,000 Brits ditch their glasses and contact lenses every year in favour of laser eye surgery. And a host of celebrities have undergone treatment, including Cilla Black, Spice Girl Mel B, Nicole Kidman and Brad Pitt. But the Consumers Association has warned that many patients are "gambling with their eyesight" because the industry...
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Posted by Admin at 01:14 PM | TrackBack

December 20, 2001

Dr. Anita Nevyas Target of FDA Regulatory Complaint

If the Nevyas Excimer Laser gains market approval from the FDA on the basis of improper data submission from its sole investigator, Nevyas, the results could be catastrophic. LASIK is an extremely popular operation, and some estimate over one-quarter of the North American population are potential patients. If a rogue device were to gain entry to this billion dollar market, where improper data could lead to it being used in favor of properly approved LASIK devices, the damages could be unimaginable.
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Posted by Admin at 01:41 PM

May 15, 1997

U.S. Marshalls Seize "Homegrown" Laser Owned by Dr. Nicholas Caro

DEPARTMENT OF HEALTH & HUMAN SERVICES May 15, 1997 Food and Drug Administration 2098 Gaither Road Rockville, MD 20850 WARNING LETTER Nicholas C. Caro, M.D. 4145 W. Peterson, Suite 200 Chicago, Illinois 60640 Dear Dr. Caro, The Food and Drug Administration (FDA) inspected your medical practice located at the above address on April 23, 1997, and determined that you have an unapproved excimer laser system, which was manufactured by Photon Data, Inc., Winter Park, Florida and assembled by [name redacted...
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Posted by Admin at 11:58 AM