ROCKVILLE, Md., Nov. 18 /PRNewswire/ -- A Florida firm whose unapproved
lasers used in eye surgery were seized last year at the request of the Food
and Drug Administration has agreed today to stop making, selling or
distributing unapproved lasers in the United States and also has agreed to the
disposition by the government of the seized products.
In a consent decree with the FDA, Photon Data Inc. (PDI), of Winter
Park, Fla., agreed to the condemnation of 10 excimer lasers and numerous
components valued at nearly $13 million and to the reconditioning of various
laser components. The reconditioning will be conducted by the firm under FDA
supervision.
The lasers, which have not been evaluated by the FDA for safety and
effectiveness, were being marketed for use to surgically correct
nearsightedness and other vision problems. The sale or use of unapproved
excimer lasers for eye surgery is a violation of the law. FDA has actively
investigated this practice in recent years and has seized a number of
unapproved lasers. The agency is concerned about the potential for serious
eye injury from the use of unapproved lasers.
PDI has agreed to pay all costs incurred as a result of the disposition of
the lasers and reconditioning of components. The laser systems will be
disposed of by the government.
The firm has agreed to pay civil fines for potential future violations of
the injunction in the amount of $25,000 per violation. The firm has agreed to
put $100,000 in escrow to pay such fines. In addition, it has agreed to
execute a $100,000 penal bond to insure that they comply with all the
conditions of the consent decree.
FDA will monitor PDI's compliance with the consent decree through
inspection of its facility.
The consent decree of condemnation and permanent injunction has been
filed in the U.S. District Court for the Middle District of Florida, Orlando
Division.
Consumer Hotline 888-INFO-FDA
SOURCE Food and Drug Administration
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Related links:
http://www.fda.gov
CONTACT:
Sharon Snider, 301-827-6242, of the FDA; or
Broadcast Media, 301-827-3434
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