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FDA is responsible for protecting the public from unsafe medical devices. Lasers used for LASIK, PRK and other forms of refractive surgery are under the purview of the FDA. Most people believe that, in general, drugs and devices approved by FDA are safe. However, many 'FDA-approved' products have later been recalled or taken off the market. FDA relied on short-term clinical trials in its approval of LASIK. Long-term safety issues and concerns have since come to light.

When a surgeon uses a laser for a procedure that is not FDA approved or performs a treatment that falls outside the approved indications, the treatment is considered 'off label'. Such uses fall under 'practice of medicine' and are not regulated by FDA.

Clinical trials for LASIK are conducted under an FDA Investigational Device Exemption. Because laser manufacturers have a huge financial stake in the clinical trial outcomes, they recruit 'top' surgeons as clinical trial investigators. Then, the investigators 'cherry-pick' the patients they enroll... patients that they know are likely to have a good result.

FDA attempts to monitor clinical trials, but the agency is spread thin...

Report Assails F.D.A. Oversight of Clinical Trials

The New York Times
By GARDINER HARRIS
Published: September 28, 2007

From the article: "The Food and Drug Administration does very little to ensure the safety of the millions of people who participate in clinical trials, a federal investigator has found..."

“In many ways, rats and mice get greater protection as research subjects in the United States than do humans,” said Arthur L. Caplan, chairman of the department of medical ethics at the University of Pennsylvania. "

Link to Article

Patient Information Booklet

LASIK Patient Information Booklets (also known as "labeling") provide data from FDA clinical trials including risks, contraindications, and warnings. FDA requires that every patient who is about to undergo refractive surgery be given the Patient Information Booklet published by the laser manufacturer. Non-compliance with this FDA mandate is widespread. Very few patients are given a booklet by their surgeon.

Click here to read a sample of the FDA mandate (page 2): "In advance of surgery, all prospective patients must receive the Patient Information Booklet (as described in your final submission to this PMA) from their treatment providers." Each FDA-approved laser has an approval order with the mandate.

If you are considering LASIK, ask the surgeon for a copy of this booklet. Patient Information Booklets are also available on the FDA website. To locate a Patient Information Booklet, click the following link: FDA approved lasers for LASIK. Then click "List All FDA-approved lasers for LASIK". The Patient Information Booklets are located under the column "Instructions".

Fox guarding the hen house?

FDA has controls in place to guard against corruption by special interests or conflicts of interest. But the individuals who presumably have the expertise to conduct clinical trials and evaluate new technology have an interest in seeing it approved.

The FDA relies on advisory committees to provide independent advice from outside experts on new medical devices that are under deliberation at FDA. Although the committee provides advice to the Agency, final decisions are made by FDA. The committee that reviews clinical trials for refractive surgery lasers is the Ophthalmic Devices Panel. Some panel members are honest scientists with a dispassionate interest in honestly evaluating the potential of new devices to serve or harm the public. Others appear to serve the LASIK industry.

The advisory committee meetings are open to the public. Transcripts of advisory committee meetings are published on the FDA website. Some interesting exchanges can be found in past FDA transcripts -- exchanges which foreshadowed problems.

Read key excerpts from FDA Ophthalmic Devices Panel meetings:

FDA meeting transcripts

Read LASIK injury reports filed with FDA

Do a search of the FDA database for reports of serious complications involving refractive surgery lasers and microkeratomes.

Type LZS for lasers or HNO for microkeratomes in the product code field. For Intralase (Intra-LASIK, blade-free LASIK, all-laser LASIK) type "IntraLase" in the Manufacturer field. Use the date range feature to customize your search.