The Ophthalmic Devices Panel met on April 25, 2008 to provide advice to the U.S. food and Drug Administration (FDA) regarding modifications to patient labeling of excimer lasers for laser-assisted in situ keratomileusis (LASIK), modifications to FDA’s LASIK website, modifications to the SightNet list of adverse events and complications emphasized for reporting in the training manual, and recommendations for recognizing the ANSI A80.11 Laser Systems for Corneal Reshaping Standard. The Panel was also asked to provide similar advice for phakic intraocular lenses (PIOLs).
Open Public Hearing sessions gave the public an opportunity to provide input. Many members of the public spoke, including patients who had experienced bad, as well as good, outcomes with LASIK surgery, and representatives from patient advocacy groups. Practicing clinicians, academic researchers, and military personnel also participated in the open public hearing sessions.
The Panel provided specific advice regarding changes to patient labeling for both LASIK and PIOL devices and their respective web sites concerning communication of risks and “Questions to Ask Your Doctor.” The panel also recommended that the SightNet training manual be revised to ensure capture of additional specific adverse events and complications.
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