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Warning on Vision Centers.

The FDA has released warning letters it had sent to the owners of five laser vision correction centers that are not complying with agency rules that govern such facilities.

Under the FDA's medical device regulations, the laser centers, which perform laser-assisted in situ keratomileusis (LASIK), are subject to certain requirements, including the reporting of adverse events.

The letters were sent in late April to five centers, some of which are part of national chains: the Lasik Vision Institute in Lake Worth, Fla., the LASIK Vision Institute in Pittsburgh, the Saint Vincent Surgery Center in Erie, Pa., the TLC Vision Corp.'s center in Plymouth Meeting, Pa., and the LasikPlus Vision Center in Concord, Calif. The agency said inspections in January had revealed that these centers were out of compliance with FDA rules.

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Title Annotation:NEWS FROM THE FDA
Publication:Internal Medicine News
Article Type:Brief article
Geographic Code:1USA
Date:Sep 1, 2010
Words:132
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