FDA to seek advice on LASIK patient information

WASHINGTON (Reuters) - The U.S. Food and Drug Administration plans to seek advice from a panel of outside experts over whether to provide more information to patients about laser eye surgery, according to documents released on Wednesday.

The FDA's comments come ahead of a public meeting set for Friday to discuss patient satisfaction with the surgery. While the agency does not regulate the procedure known as LASIK, or laser-assisted in situ keratomileusis, it does oversee the equipment used.

Since it was first approved in the mid-1990s, more than 12 million Americans have undergone LASIK by some estimates. Industry experts and doctors agree most patients are satisfied, but the FDA has received some complaints of blurriness, dry eye and other side effects.

In an FDA memo released on Wednesday, the agency said it would ask its outside experts to discuss what information is currently available for patients considering or undergoing LASIK and whether changes must be made.

"Panel members will be asked to recommend modifications/additions to the FDA's patient labeling and LASIK Website," the FDA wrote.

The FDA also said it will seek advice on how to gather more clinical data.

The meeting is expected to draw testimony from patients with strong opinions on the procedure, either because they suffered a mishap, or because their lives have improved without having to use glasses or contacts.

Analysts have said that could weigh on LASIK device makers such as Advanced Medical Optics Inc, Alcon Inc and Bausch & Lomb as well as LASIK providers such as TLC Vision Corp and LCA-Vision Inc.

Advanced Medical Optics shares were off nearly 1.4 percent at $20 in early afternoon trading, while Alcon shares were up 0.4 percent at $152.15, both on the New York Stock Exchange.