FDA to Address Complaints Related to LASIK Eye Surgery

David Mittleman

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In recent years, LASIK eye surgery has become increasingly popular. In fact, an estimated 6 million patients have undergone the surgery since its inception. While eye surgery advocates cite that 95% of patients are satisfied with the results of the surgery, the Food and Drug Administration has received some complaints. Specifically, the FDA said it received 140 LASIK-related complaints between 1998 and 2006. However, the FDA has not yet taken the time to investigate the reported issues with LASIK, including permanent damage to the eyes such as double vision, dry eyes, and “halos” appearing around objects at night.

But now the FDA says it will work with the National Eye Institute and the Department of Defense to determine the percentage of patients who experience adverse side effects. The first phase of the project has already begun, which is sending questionnaires to patients to fill out after receiving the surgery. The second phase includes a clinical trial that will track patients who received the surgery, which will end by 2012. The FDA also sent warning letters out to 17 LASIK recently for failing to adequately report the adverse side effects of LASIK surgery.

LASIK procedures have fallen off in popularity in the last few years with the continuing economic crisis. The procedure is rather pricey, with an estimated cost between $1,500 and $5,000.