Refractive Surgery News

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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Lasik's Blurry Vision, by Abby Ellin

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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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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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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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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Lasik Patients Tell FDA Panel About Injuries

Although public comments presented to the Ophthalmic Devices Panel of FDA’s 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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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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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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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 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...
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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 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...
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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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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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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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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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Dr. Thomas Tooma Violates FDA Safety Protocols

Excerpt from the FDA warning letter: "The purpose of this Warning Letter is to inform you of objectionable conditions found during a Food and Drug Admininstration (FDA) inspection of your clinical site, to discuss your written response to the deviations noted, and to request a prompt reply with regard to the remaining issues. The inspection took place during the period of December 22, 1999 and January 13, 2000, and was conducted by Mr. ALlen F Hall, an investigator from FDA's...
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Dr. David Dulaney Violates FDA Safety Protocols

Excerpt from FDA warning letter: "The purpose of this letter is to warn you that your [redacted] system (the [redacted] located at the Barnet Dulaney Eye Center in Mesa, Arizona, may not be used to treat patients beyond the conditions of approval of your investigational device exemption (IDE). Any use of the [redacted] beyond the terms of the FDA-approved IDE is in violation of federal law. 21. U.S.C. § 351(f)(1)(B). As discussed further below, inspection of your facility by the...
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Dr. Philip Roholt Violates FDA Safety Protocols

Excerpt from the FDA warning letter: "On February 19-20, 1997, the Food and Drug Administration (FDA) inspected the former site of your medical practice in Green, Ohio and on May 13, 1997, we inspected your current location in North Canton, Ohio. These inspections revealed that you are continuing to use an unapproved excimer laser system, which was manufactured by Photon Data, Inc., Winter Park, Florida, and assembled by yourself and Mr. Chung Lee, consultant with Nexus Technology, Inc., Ovledo, Florida."...
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