UPDATE: FDA Warns 17 Lasik Centers About Subpar Reporting
(Includes comment from LCA-Vision, updates stock prices.)
DOW JONES NEWSWIRES
The U.S. Food and Drug Administration has issued warning letters to 17 Lasik
vision-correction ambulatory surgical centers after inspections found inadequate
reporting systems.
The inspections didn't find problems with the use of Lasik devices at the
centers, the FDA said.
"Ambulatory surgical centers that perform Lasik must maintain a robust
reporting system as required by law," said Dr. Jeffrey Shuren, acting director
of the FDA's Center for Devices and Radiological Health. "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."
TLC Vision Corp. (TLCV) issued a release Thursday night, saying six of its
centers were inspected by the FDA in the past four months. One center was found
to need additional written procedures, as outlined in a letter TLC received from
the FDA on Aug. 20.
President and Chief Executive James Tiffany said the company responded soon
thereafter, adding that, "Neither the inspection nor the observations from the
inspection related to device safety or efficacy of the Lasik procedure."
Mike Celebrezze, a spokesman for rival LCA-Vision Inc. (LCAV) said Friday that
14 of the company's centers were visited by FDA officials between June and
August, with no reporting errors found. "But they felt our policy for reporting
wasn't as strong as they would have liked, so we have revised and updated our
policies," he added.
The news comes as laser-vision correction procedures have slumped for more
than a year amid the recession. The work typically isn't covered by health
insurance.
Shares of TLC were recently up a penny at 29 cents while LCA-Vision was down 4
cents at $5.70.
-By Nathan Becker, Dow Jones Newswires; 212-416-2855; nathan.becker@
dowjones.com;
(END) Dow Jones Newswires
10-16-091209ET
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