FDA
TALK PAPER

T97-21                          Sharon Snider:    301-443-3285
June 9, 1997                    
                                Consumer Hotline: 800-532-4440 


              FDA AUTHORIZES SEIZURE OF UNAPPROVED LASERS

     As part of a move to prevent the sale and use  of unapproved
lasers used in  eye surgery, the Food and Drug Administration 
today requested  U.S. marshals  seize excimer lasers made by 
Photon Data Inc., of Winter Park, Fla.  The lasers, which were
not reviewed by FDA for safety and effectiveness,  were being
sold to permanently reshape the cornea to treat nearsightedness
and other eye conditions.
     Approximately nine excimer lasers and components at an
estimated value of  over $3 million were seized at two  Photon
Data locations and at a private freight forwarder used by the
company. 
     The sale or use  of  unapproved excimer lasers is a
violation of the law.  FDA has been investigating this practice
in recent months, and plans to take enforcement action  against
other   unapproved excimer lasers on the market. 
     FDA is concerned about the potential for serious eye injury
from such lasers because the manufacturers have failed to provide
the scientific data and information  necessary to show that these
products  are safe and effective for treating patients. 
               Such information includes success rates, number of adverse
events, and  critical safety engineering information.  Physicians
using these lasers may  not have enough information to adequately
counsel patients  about the benefits
and risks of treatment.
     Recently, the agency's concern has been heightened by 
reports of serious eye injuries, such as permanently damaged
eyesight or temporary blindness requiring a corneal transplant.  
FDA is currently seeking  more information about these injuries. 
The agency is encouraging patients who have been injured, or
doctors who are aware of such injuries, to inform  FDA's MEDWatch
service by phone (1-800-FDA-1088), by fax (1-800-FDA-0178), or by
modem (1-800-FDA-7737). 
     Only two lasers are currently approved by FDA for refractive
eye surgery.  They are manufacturered  by Summit Technology  Inc.
of Waltham, Mass., and Visx Inc., of Santa Clara, Calif.  Both
companies conducted clinical studies to show that their lasers
could treat nearsightedness safely and effectively using a
procedure called photorefractive keractectomy (PRK).  In
addition, a Visx  excimer laser has been shown to be safe and
effective for treating astigmatism.  Clinical studies are
extremely important in the development of these devices.  Through
the studies, the manufacturers learn the characteristics of the
product,  how to fine tune it,   how to maximize good results,
and how to minimize adverse outcomes  such as making vision worse 
than it was before the patient came in for surgery. The two
approved lasers are clearly labeled with instructions for the
practitioners.  FDA requires that physicians be trained in their
use, and that prospective patients be given a brochure explaining
expected and potential problems.
     A number of other lasers for eye surgery are currently being
tested  in FDA-sanctioned clinical studies to determine their
safety and effectiveness.
     People considering laser surgery for nearsightedness or
astigmatism should ask their doctor if the laser being used is an
approved Summit or Visx product.  If  it is not, they should make
sure they are being treated with a laser  that is part of an 
FDA-sanctioned clinical study.
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