FDA
TALK PAPER

Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available. 

T97-52                       Sharon Snider:       301-827-6242
Oct. 22, 1997                
                             Consumer Inquiries:  800-532-4440


                UPDATE ON UNAPPROVED EXCIMER LASERS

     The Food and Drug Administration is taking action against
unapproved excimer lasers that are being used to treat
nearsightedness and other eye conditions.  Such unapproved lasers 
pose a risk to patients because their use could potentially cause
serious eye injury.   FDA is also urging patients to verify that
their laser surgery is being done only with an approved laser or
in an FDA-monitored clinical study.
     In the past few months, FDA has asked U.S. Attorneys to
initiate seizures of lasers from a manufacturer and at three eye
clinics.  The manufacturer and eye clinics had all ignored prior
warnings from FDA.
     U.S. marshals have seized unapproved lasers from the
following locations:
     * June 9 -- Photon Data Inc., Winter Park, Fla. -- Nine
unapproved excimer lasers and components valued at over $3
million seized at two company locations.
     * July l -- Woodhams Eye Clinic, Atlanta, Ga. -- One 
unapproved excimer laser seized from the office of J. Trevor
Woodhams, M.D.
     * August 28 -- Neumann Eye Institute, Deland, Fla. -- One
unapproved excimer laser seized from the office of Albert C.
Neumann, M.D.
     * August 28 -- Pro Cargo, Miami, Fla. -- One additional
unapproved excimer laser manufactured by Photon Data Inc. seized
at this private freight forwarder.
     * Sept. 2 -- St. George Corrective Vision Center, Chicago,
Ill. -- One unapproved excimer laser seized from the office of 
Nicholas Caro, M.D.
     In the past three years, FDA has issued 24 warning letters
to manufacturers and physicians regarding the sale and use of
unapproved excimer lasers.  The agency is continuing to
investigate this activity and plans to take additional
enforcement action.
     Only two lasers are currently approved by FDA for refractive
eye surgery.  They are manufactured by Summit Technology, Inc.,
of Waltham, Mass., and VISX, Inc., of Santa Clara, Calif.  Both
companies conducted clinical studies to demonstrate that their
lasers could treat nearsightedness safely and effectively using a
procedure called photo refractive keratectomy (PRK).  In this
procedure, the surgeon permanently reshapes the cornea by using
the laser to deliver bursts of ultraviolet light that vaporize
precisely targeted corneal tissue.  The effect is to flatten the 
cornea.  In addition, a VISX excimer laser has been shown to be
safe and effective for treating astigmatism, distorted vision 
caused by an uneven curvature of the cornea.
     Recently, the American Academy of Ophthalmology adopted a
policy that lasers should be used for refractive surgery only if 
the lasers are approved by FDA or are used under FDA-sanctioned
clinical studies and are being operated under an experimental
protocol approved by an institutional review board.
      Clinical studies are extremely important in the development
of these lasers.  Through these studies, the manufacturers learn
the capabilities and characteristics of the product, how to fine
tune it, how to maximize good results, and how to minimize
adverse outcomes.  (PRK can occasionally make vision worse than
it was before the patient came in for surgery.)  Furthermore,
clinical studies are important for determining which patients
will best benefit from use of the device.  Also, during these
studies, physicians learn how to perform the surgery to yield the
best outcome for the patient.  Information obtained during the
studies is included on the device labeling when the laser is
approved for marketing.
     The two approved lasers are clearly labeled with
instructions for the safe, effective use of the device.  FDA
requires that physicians be trained in use of the lasers, and
that prospective patients be given a brochure explaining expected
results and potential problems associated with refractive 

surgery.
     A number of other excimer lasers for eye surgery are 
currently being tested in FDA-sanctioned clinical studies to
determine their safety and effectiveness. 
     FDA urges people considering laser surgery for
nearsightedness or astigmatism to 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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