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FDA Panel Urges Clearer LASIK Warnings

Consumers should be told of the risk of complications

April 28, 2008

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A U.S. Food and Drug Administration panel says the agency should require enhanced warnings about the risks associated with LASIK eye surgery, an increasingly popular procedure to correct vision.

The group, which has been studying the issue for a year, says the surgery has a very high success rate, indicating that more than 95 percent of patients have expressed satisfaction with the results. Its study was prompted by the 140 patients who have written letters of complaints to the FDA.

The panel says consumers should understand the potential for complications, and thus be given warnings in more clear, concise language.

Complaints have included eye pain, dry eyes, blurred or double vision, and other problems.

The panel's recommendations include adding photographs to show what people suffering certain side effects actually see. Some patients have complained that glare can create starbursts of light.

The panel also says the warning should make clearer the conditions that should disqualify someone from LASIK, such as large pupils or severe nearsightedness.

An estimated 7.6 million consumers have had the LASIK procedure performed since the mid 1990s.

The LASIK procedure, developed in 1990, involves cutting a thin flap on the eye and folding it to enable remodeling of the tissue underneath with a laser. The flap is then repositioned.

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