FDA panel to review laser eye surgery

Agency advisors to focus on the quality of patients’ lives after procedure

updated 12:00 p.m. ET March 18, 2008

SILVER SPRINGS, Md. - U.S. health regulators plan to review whether a popular type of laser eye surgery is improving patients’ lives, a senior Food and Drug Administration official said on Monday.

Dr. Daniel Schultz, director of FDA’s Center for Devices and Radiological Health, said a number of concerns have been raised concerning patient satisfaction with the vision correction procedure, known as laser-assisted in situ keratomileusis, or LASIK.

An agency advisory panel will hold a public meeting to discuss the issue, Schultz said, but he did not give a date.

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Companies that could be affected by such a meeting include LASIK device makers such as Advanced Medical Optics Inc, as well as LASIK providers such as TLC Vision Corp and LCA-Vision Inc.

“Obviously, it’s a technology that has caught on and is used very, very widely. And there have been questions raised in terms of ... quality of life and what does it actually do for the patient as opposed to the technology itself,” Schultz told reporters.

Shultz said the meeting will focus on the quality of patients’ lives after surgery.

Known complications from the procedure can include dry eyes, glare, double vision, an increased risk of corneal inflammation or infection, and blindness.

In July 2007, the FDA responded to petitions from an individual asking for a halt to the procedures and a withdrawal of their approval. The agency said the devices were safe and effective but advisory panel discussions “could complement” its other safety monitoring.

“The postmarket information found within our databases, regarding the devices mentioned in your petitions, does not suggest that at this time, there are adverse events that are unanticipated or occurring at an unexpected rate,” the FDA said at the time.

FDA spokeswoman Karen Riley said the meeting date has not been made public, although some analysts have said it could happen as early as next month. The agency’s eye-related panel is tentatively scheduled to meet April 24-25, May 15-16, September 18-19 and November 20-21.

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