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

April 17, 2010

FDA Mismanagement of Lasers Used in LASIK Eye Surgery Described by Former Regulator

Excerpts of a letter from Morris Waxler, a former FDA regulator, to Dean Kantis show how the FDA mismanaged its approval of lasers used in LASIK eye surgery: LASIK-induced eye injuries occur, in part, because FDA did not ensure that manufacturers have adequate design controls, fault tree analyses, and correction and prevention procedures, including, but not limited to, adverse event definitions, MDR reportable events, trend analysis, and root cause analyses. The agency also did not compare the safety and effectiveness...
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Posted by Admin at 02:05 PM

February 25, 2010

Former FDA Regulator Says LASIK Side Effects Weren't Taken Seriously Enough

By Lisa Start, Alberto Orso, Joseph Brownstein LASIK eye surgery has provided the promise of a quick vision fix for millions of Americans, but now one of the Food and Drug Administration regulators who approved the procedure in the 1990s is publicly expressing concerns about its safety. Some 700,000 people a year in the U.S. get LASIK surgery to correct their vision, and in the years since the procedure was approved, the majority of patients have been happy with...
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Posted by Admin at 11:34 PM

January 25, 2010

Dr. Nicholas Caro Barred from Performing LASIK Eye Surgery

By Deborah L. Shelton, Tribune reporter 8:25 PM CST, February 19, 2010 A state regulatory agency is barring a Chicago ophthalmologist from performing Lasik eye surgeries in Illinois, one of a number of disciplinary actions taken against the doctor on Friday. After finding that Dr. Nicholas Caro had engaged in unprofessional conduct and gross negligence, the Illinois Department of Financial and Professional Regulation suspended his medical license for 30 days, placed him on probation for a minimum of 3 years...
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Posted by Admin at 11:24 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 17, 2008

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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Posted by Admin at 12:56 PM | Comments (1)

September 24, 2008

LASIK Dissidents Launch 'LasikFDA' Web Site

Jim Dickinson Editor, FDA Webview & FDA Review A group of LASIK dissidents, led by injured patient Dean Kantis, have launched a Web site called LasikFDA.com "to expose deceit, corruption, and collusion by the FDA and the LASIK industry. You've read the hype about the 10-minute miracle. Now get the truth." To disown confusion its look-alike name might invite, its home page prominently declares: "This is not the FDA Lasik site. The FDA Lasik site is here," with a live...
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Posted by Admin at 03:19 PM

May 14, 2008

Lasik Patients Tell FDA Panel About Injuries

Although public comments presented to the Ophthalmic Devices Panel of FDAís Medical Devices Advisory Committee 4/25 included ample reference to physical side effects and complications associated with Lasik eye surgery, the session was dominated by patient anecdotes and professional dispute over reports of severe depression and suicidal thoughts and actions attributed to adverse or sub-optimal surgical outcomes. Common physical complaints by patient advocates and patients claiming to have suffered adverse effects from Lasik surgery included persistent pain and stinging...
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Posted by Admin at 04:52 PM

April 25, 2008

Lasik Patients Complain to Panel

By Sabine Vollmer, Staff Writer  New and Observer 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...
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Posted by Admin at 04:11 PM

April 24, 2008

FDA Holds Sham Hearings on LASIK "Safety"

Editorial by Brent Hanson With much fanfare the FDA has made an announcement that it will hold hearings on April 24-25 to listen to complaints from the public regarding LASIK eye surgery.  While many LASIK patients with bad outcomes hold high hopes that the FDA will ban or restrict this defective medical procedure, a clear understanding of the FDA and its role in "protecting" public health reveals that the FDA does not have the legal authority to ban the procedure,...
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Posted by Admin at 06:31 AM

March 24, 2008

FDA Sets Date to Hear from LASIK Patients, Doctors

By Sabine Vollmer, Staff Writer The first public hearing on how complications from laser eye surgery affect a patientís 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...
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Posted by Admin at 08:29 PM

March 20, 2008

LASIK Critics Feel Shunned by FDA

Info on Hearing is Scarce, Patients Say Sabine Vollmer, Staff Writer As federal regulators prepare to hold their first hearing on how complications from laser eye surgery affect a patientís 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...
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Posted by Admin at 08:25 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

January 07, 2005

FDA Approves Device for the Diagnosis and Management of Glaucoma in LASIK Patients

RetinaPharma announces FDA-clearance of TonoPach device for glaucoma determination:  new  technology especially important for diagnosis and management of glaucoma in LASIK patients RetinaPharma, a privately-held portfolio company of the Hopkins Capital Group, LLC, announced today that it has received 510(k) FDA clearance to market its unique, patented device that enables more accurate intra-ocular pressure (IOP) determination in patients. The device, TonoPach (TM), provides for the unprecedented simultaneous determination of intra-ocular pressure and corneal thickness at the same location on the...
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Posted by Admin at 04:50 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

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