The FDA also announced that it has issued warning letters to 17 LASIK ambulatory surgical centers following inspections that revealed inadequate adverse event reporting systems within the centers. The inspections had taken place over the last several months with some inspections still pending. The inspections did not find problems with the actual use of the LASIK devices at these facilities.

"Many people in the U.S. undergo LASIK procedures," Shuren stated about the inspections. "Ambulatory surgical centers that perform LASIK must maintain a robust reporting system as required by law. Reporting adverse events to the FDA is critical to better understand the safety and effectiveness of ophthalmic lasers used in LASIK procedures and to enable the FDA to take appropriate actions where the lasers do not meet safety and effectiveness requirements."


Adapted in part from an FDA press release.

Read more:

Link: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm186858.htm

http://www.aao.org/eyesmart/correction/lasik.cfm

LASIK Surgery News: http://www.lasiksurgerynews.com/news/How-popular-is-LASIK-surgery.shtml

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