Post-LASIK Vision Correction Quality-Of-Life Will Be Reviewed By FDA Panel
This article was originally published in The Gray Sheet
Executive Summary
FDA's Ophthalmic Devices Advisory Panel will address quality-of-life issues following LASIK laser vision correction surgery on the second day of its upcoming April 24-25 meeting
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A home for LASIK comments
FDA establishes a dedicated docket for public comments on post-market experience with LASIK laser vision correction surgery, the agency announces Sept. 12. After updating its LASIK Web site and strengthening post-market surveillance activities, FDA says it wants to better understand post-treatment quality-of-life issues. LASIK complications have taken a high-profile in recent months, and on May 19 yet another citizen petition was filed urging FDA to ban the devices (1"The Gray Sheet" March 24, 2008, p. 6). Comments may be submitted to FDA-2008-N-0488 through Sept. 14, 2009
A home for LASIK comments
FDA establishes a dedicated docket for public comments on post-market experience with LASIK laser vision correction surgery, the agency announces Sept. 12. After updating its LASIK Web site and strengthening post-market surveillance activities, FDA says it wants to better understand post-treatment quality-of-life issues. LASIK complications have taken a high-profile in recent months, and on May 19 yet another citizen petition was filed urging FDA to ban the devices (1"The Gray Sheet" March 24, 2008, p. 6). Comments may be submitted to FDA-2008-N-0488 through Sept. 14, 2009
LASIK Panel Reaches Consensus On Labeling Changes
Patient labeling for LASIK laser vision correction systems should be modified to include graphics of what potential visual side effects like halos and starbursts could look like, according to FDA's Ophthalmic Devices Panel