Description of Event or Problem · 1
CONSUMER REPORTS EYE DAMAGE RESULTING FROM LASIK SURGERY USING AN EXCIMER LASER, PERFORMED TO CORRECT NEARSIGHTEDNESS. THE SURGERY WAS PERFORMED ON 12/4/97 ON BOTH EYES. RIGHT EYE NOW HAS 20/60 VISION (20/40 WITH GLASSES). THE LEFT EYE HAS 20/100 VISION-NOT CORRECTABLE. CONSUMER HAS DOUBLE VISION. CONSUMER WAS TOLD BY PHYSICIAN THAT HER VISION IS FINE. SHE HAS SINCE SEEN AT LEAST 2 DRS WHO TOLD HER PROBLEM WAS NOT TREATABLE. CONSUMER REPORTED VIEWEING A VIDEOTAPE ON THE LASIK PROCEDURE PRIOR TO THE SURGERY. SHE BELIEVES THE VIDEOTAPE WAS PRODUCED BY THE LASER MFR. THE COMPLAINANT DESCRIBED SCARRING OF HER LEFT CORNEA AS A RESULT OF COMPLICATIONS WITH MAINTAINING SUCTION PRESSURE DURING THE CUTTING OPERATION WHICH TOOK PLACE DURING LASIK REFRACTIVE SURGICAL PROCEDURE PERFORMED AT A CLINIC ON 12/4/97. DURING VISITS TO THE CLINIC ON 7/24 AND 29/98, INVESTIGATOR LEARNED THE ATTENDING PHYSICIAN USED A MICRO KERATOME (CUTTING/SUCTION DEVICE) CALLED THE "FLAPMAKER" TO CUT THE CORNEA, AND THEN USED VISX STAR (MODEL C) EXCIMER LASER TO DISSOLVE CORNEA TISSUE UNDERLYING THE CORNEAL FLAP. THE LASER APPEARS TO BE APPROVED FOR USE WITH PRK SURGERY AND WAS USED BY THE PHYSICIAN FOR LASIK SURGERY UNDER MED DISCRETION IN CONSULTATION WITH HIS PT. DR BECAME AWARE OF THIS "FLAPMAKER" AT A MEETING IN OCTOBER 1997. THE CLINIC PURCHASED THE "FLAPMAKER" IN DECEMBER 1997 FROM REFRACTIVE TECHNOLOGIES, INC, CLEVELAND, OHIO AND DR HAS USED THIS DEVICE FOR LASIK PROCEDURES AT HIS EYE SURGERY CLINIC SINCE THAT TIME. SHE SAID HER SISTER, WHO WAS VERY NEARSIGHTED, HAD THE SURGERY AT THE CLINIC WITH GOOD SUCCESS-SHE DID NOT HAVE TO WEAR EYE GLASSES FOLLOWING THE SURGERY. HER SISTER HAD PRK IN ONE EYE AND LASIK IN THE OTHER EYE. THE COMPLAINANT FELT THIS CLINIC WAS WELL KNOWN AND HAD BEEN IN BUSINESS FOR A LONG TIME, SO SHE MADE AN APPOINTMENT FOR A CONSULTATION ABOUT THE SURGERY. IN NOVEMBER, 1997, AT THE CONSULTATION, SHE SAW A REFRACTIVE SURGERY COORD WHO GAVE HER AN EYE EXAM WHICH INCLUDED AN EYE SCAN TO EVALUATE THE TOMOGRAPHY OF HER EYES. SHE WAS TOLD SHE DID NOT QUALIFY FOR PRK SURGERY BECAUSE HER EYES WERE TOO MYOPIC, BUT SHE WAS A GOOD CANDIDATE FOR LASIK SURGERY AND WOULD NOT NEED TO WEAR EYE GLASSES FOLLOWING THE SURGERY. SHE TOLD REPORTER HER VISION WAS -10.2 RIGHT EYE AND -11.5 LEFT EYE. DR SAID HER ASTIGMATISM WAS MINOR AND SHE WOULDN'T NEED AN ADDED PIECE FOR SURGERY. HE SAID SHE WOULD NOT NEED GLASSES AFTER THE SURGERY-SHE DIDN'T WANT THE SURGERY IF SHE HAD TO CONTINUE TO WEAR GLASSES. SHE READ PT LITERATURE, AND VIEWED A VIDEO TAPE ABOUT LASIK SURGERY ON 11/19/97. SHE SIGNED A PT INFORMED CONSENT ON 11/19/97 AND AUTHORIZED SURGERY BE ACCOMPLISHED FOR BOTH EYES. THE COMPLAINANT SAID SURGERY WAS PERFORMED ON HER RIGHT EYE FIRST, THEN ON HER LEFT EYE. SHE EXPLAINED THAT DURING THE SURGERY ON 12/4/97, DR HAD SOME TROUBLE WITH THE SUCTION UNIT PLACED AGAINST HER LEFT EYE.