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UPDATE 2-US warns LASIK clinics over side effect reporting

Fri Oct 16, 2009 3:35am IST
 
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* FDA says 17 centers have poor reporting systems

* More FDA inspections pending

* TLC Vision, LCA Vision clinics among those cited

* TLC shares close down 3.4 pct, LCA shares down 1.7 pct (Adds details on clinics, company comment, share prices, byline)

By Susan Heavey

WASHINGTON, Oct 15 (Reuters) - More than a dozen LASIK eye centers have poor systems in place to report any side effects in patients who have undergone the vision correction surgery, U.S. health regulators said on Thursday.

There were no problems found with the laser devices used in the procedure, but U.S. Food and Drug Administration inspectors found problems with side-effect reporting systems at 17 LASIK vision correction centers.

Warning letters were sent to the clinics, including some TLC Vision Corp (TLC.TO: Quote, Profile, Research) (TLCV.O: Quote, Profile, Research) and LCA Vision Inc (LCAV.O: Quote, Profile, Research) centers.

More inspections are pending, the FDA said. Clinics are required to report side effects to equipment manufacturers and the FDA.  Continued...

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