Friday, April 12, 2024

FDA Considers Adding Warnings for LASIK Surgery Patients

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For anyone considering LASIK eye surgery—as many as 600,000-700,000 people undergo it a year—the Food and Drug Administration has a warning for you. The FDA has issued a draft guidance to warn patients about potential side effects like double vision, dry eyes, difficulty driving and chronic eye pain. The warning may be surprising for the countless satisfied LASIK patients who receive the treatment each year, but the government agency says its re-evaluating their stance on the safety of the surgery.

The laser eye surgery that is done to improve eyesight is performed using a laser to reshape the cornea. In the guidance document drafted by the agency this summer, they propose that patients be given a “patient decision checklist” which states that corneal tissue is “vaporized” during the surgery and explains the risk of corneal nerves never recovering from incisions. They also want to patients to understand that despite having the surgery they may need glasses again in the future.

According to officials, more than 600 individuals and professional groups have weighed in with comments since the draft of the guidance was made public in July, and the agency is now reviewing the input while preparing the final documents. As for if and when the guidance will be finalized, that is yet to be determined. In a statement, an FDA spokesperson shared that the public comment period for the draft guidance closed in November. “With the comment period now closed, the FDA is now reviewing and considering comments for the final guidance,” they explained. “The timeline for the final guidance issuing is dependent on a number of factors and we cannot provide a firm timeline at this point.”

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