Refractive Surgery News

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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Democrats Probe "Corrupted" FDA Reviews of Devices (Update1)

By Justin Blum Nov. 17 (Bloomberg) -- Top managers with the U.S. Food and Drug Administration ``corrupted and interfered with'' scientific reviews of medical devices, agency scientists said in a letter that is sparking a congressional investigation. The House Energy and Commerce Committee will review ``compelling evidence'' that devices were approved in violation of laws to ensure their safety, said Representatives John Dingell, the panel's chairman, and Bart Stupak, a member, in a statement today. The FDA has repeatedly come...
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Class Action Lawsuit Filed Against Nidek and Multiple Surgeons for Illegal Medical Experiments

A medical device maker and more than a dozen California ophthalmologists are named in a federal class-action suit filed on behalf of patients who had vision correction surgery with an unapproved experimental Lasik tool.

The suit alleges that Japan-based Nidek Co. and two U.S. subsidiaries conspired with the doctors and four vision care facilities to perform procedures to correct farsightedness from 1996 to 2006 using a laser tool that the Food and Drug Administration had certified only for clinical trials on nearsighted patients.

Lead plaintiff Robert Perez filed the suit in the U.S. District Court for the Southern District of California after learning in October that the Lasik surgery he underwent in 2002 to correct farsightedness was performed with a Nidek EC-5000 Excimer laser system.

Nidek was authorized to use the device only for preliminary testing on nearsighted patients, according to the complaint.

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Alcon Sued for Products Liability Due to Recall of Defective LADAR6000 Excimer Laser

Jenna Reed and Rian Reed vs. Alcon Laboratories, Inc., Alcon Manufacturing, Ltd., and Alcon Refractive Horizons, Inc. United State District Court, District of Colorado. Denver, CO (PRWEB) August 24, 2008 -- On August 20, 2008, plaintiffs, Jenna Reed and Rian Reed, filed their complaint in the United States District Court, District of Colorado, seeking damages against Alcon for strict liability, negligence, breach of warranty, misrepresentation, and violation of the Colorado Consumer Protection Act. Case Number 1:08-cv-01759-EWN Reed et al v....
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Glenn Hagele / USAEYES / CRSQA Promotes Junk LadarVision Lasers

Glenn Hagele who operates a surgeon referral service known as CRSQA and USAEYES published the following statement at alt.lasik-eyes on December 22, 2005. 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",...
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VISX, Laser Vision Centers, and Dr. Tom Morrison Sued by Cheryl Atchison for Medical Malpractice and Use of a Defective Device

The LASIK surgery was first performed on plaintiff’s right eye. While approximately midway through performing the LASIK surgery procedure on the left eye, defendant Morrison and Tri-Lakes discontinued the procedure. The laser stopped prematurely and/or the fluence became out of range causing an asymmetric treatment, furrow or trough in the stroma and/or more ablation to be received in a portion of the left eye of plaintiff when the surgery was being performed, causing damage to her eye.
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Sales of Alcon's Malfunctioning LadarVision Lasers Falls

Revenue from refractive surgery, commonly known as LASIK surgery, dropped almost 9 percent as equipment sales fell. The complete article is available at www.dfw.com/mld/dfw/business/10864465.htm...
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Texas Woman Sues Alcon after being Damaged by Malfunctioning LADARVision Laser

Victim says eyes were injured by Alcon Laser System Dallas, TX (PRWEB via PR Web Direct) February 4, 2005 -- A Lubbock County, Texas woman is suing the Fort Worth maker of a laser system used by doctors to perform LASIK eye surgery. According to the lawsuit, Sandra Brown v. Alcon Manufacturing, L.T.D. and Alcon Laboratories, Inc., the LADARVision laser is defective (Case #236-209603-05 District Court Tarrant County Texas 236th Judicial District). The lawsuit accuses Alcon of ignoring warnings that...
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CBS News Airs Report on Malfunctioning Alcon LadarVision Lasers

Fort Worth-Made LASIK Surgery Machine Under Fire More Patients Claiming LASIK 'LASIK Casualty" Status By Investigator Ginger Allen Producer/Photojournalist: Dave Manoucheri At the turn of the millennium, it was the wave of the future--Peel back the lens of your eye, and look forward to sight you never imagined. It is the possibility of regaining 20/20 vision. Sandra Brown saw hope. Three years ago, Brown had Lasik surgery. The pediatric eye surgeon was well aware of the risks associated with the...
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Alcon Sued by Dr. Sandra Brown for Damage by Malfunctioning LadarVision Laser

CAUSE NO. 236 209603 05 SANDRA BROWN, Plaintiff, vs. ALCON MANUFACTURING, L.T.D., and ALCON LABORATORIES, INC. IN THE DISTRICT COURT OF TARRANT COUNTY, TEXAS. PLAINTIFF'S ORIGINAL PETITION, MOTION FOR LEVEL THREE DISCOVERY PLAN AND REQUEST FOR DISCLOSURE TO THE HONORABLE JUDGE OF SAID COURT
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ALCON Accused of Criminal Conduct in Concealing Reports of Defective LadarVision Lasers

GE HEALTHCARE FINANCIAL SERVICES, a component of GENRAL ELECTRIC COMPANY, Plaintiff, v. EBW Laser, Inc. Defendant. Third Party Plaintiff, v. ALCON LABORATORIES, INC., and REFRACTIVE HORIZONS, L.P. Third Party Defendants.
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Fox News Airs Report on Malfunctioning Alcon LadarVision Lasers

Mark Saxenmeyer interviews Dr. Kent Kirk, and Doug Harris, an attorney for EBW, a laser leasing company which is suing Alcon for selling defective LadarVision lasers.  Incriminating documents and a taped telephone conference call with the former of CEO of Alcon, Tim Sear, are presented.  The taped conference call includes conversations with surgeons Dr. Joseph Dello Russo, Dr. David Dulaney, and Dr. Herman Sloane. A copy of the report is available here (96 MB file in MPG format)....
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VISX Accused of Submitting Falsified Data to the FDA

VISX reported that 97.7% (84/86) of eyes had UCVA of 20/20 or better at 12 months. These 86 eyes represent only 24.5% of patients. Accountability is reported to be 95.6%, despite the fact that 70.7% (248/351) of patients were labeled “not yet eligible” for analysis at 12 months.
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Surgeons Accuse Alcon of Concealing Reports of Defective Lasers

"Fears that grew over 'perfect' operation"  LASER eye surgery, by offering patients near-perfect sight in one quick operation, has become a billion-pound industry, using the latest technology to generate vast profits. From the biggest players such as Alcon, a £2 billion eyecare company, to the hundreds of sought-after ophthalmologists, the stakes could not be higher. When a number of doctors from across America began to question whether Alcon's Ladarvision system, a machine using Nasa laser technology, was malfunctioning, the company...
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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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Techniques for Dismantling a Jammed Microkeratome During Surgery

Failed Microkeratome Reversal of Forward Pass The only unusual aspect of this procedure was that the machine jammed. By Robert E. Tibolt, MD A frustrating aspect surgeons will inevitably encounter is a mechanical malfunction. In both cataract and refractive surgery, we are dependent on the tools we use to improve our patients' visual acuity. When something goes wrong, we must be prepared mentally for a quick and accurate response to assure a successful outcome for our patients. I hope...
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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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