SURGEON REPORTED TO CO'S MEDICAL DIRECTOR THAT THE APPLANUTOR HAD BEEN PUT ON THE SAPPHIRE UPSIDE DOWN. THE FLAP WAS SO THICK IT HAD TO BE HELD BACK. LASIK WAS PERFORMED WHILE HOLDING THE FLAP BACK. THERE WAS A PERFORATION WHICH CAUSED LEAKAGE. PATIENT HAD MINIMAL VISION AT POST-OP. PATIENT WAS DOING WELL AS OF 7/11/99.

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SURGEON REPORTED TO CO'S MEDICAL DIRECTOR THAT THE APPLANATOR WAS PUT ON UPSIDE DOWN. THE FLAP WAS SO THICK IT HAD TO BE HELD BACK. LASIK WAS PERFORMED ON PT WHILE HOLDING THE FLAP BACK. THERE WAS A PERFORATION WHICH CAUSED LEAKAGE. PT SUTURED. AT POST-OP, THERE WAS SIGNIFICANT EDEMA AND THE PT HAD MINIMAL VISION AT THE TIME. PT WAS DOING WELL AT 7/11/99. PLEASE NOTE THAT THE FIRST REFERENCED EVENT HAS BEEN FILED BEYOND THE REQUESTED TIME FRAME. THE SECOND FILING IS WITHIN THE PRESCRIBED TIME FRAME. THE REASON FOR THIS LATE REPORT IS AS FOLLOWS: UPON CO'S INITIAL REVIEW OF THE FIRST EVENT, CO DETERMINED THAT, BECAUSE CO'S MICROKERATOME SYSTEM DID NOT "CAUSE" THE PERFORATION DESCRIBED IN THE REPORT, CO DID NOT FEEL IT NECESSARY TO FILE. THE EXCIMER LASER WAS THE DEVICE THAT CAUSED THE PERFORATION OF THE ANTERIOR CHAMBER DUE TO THE THINNESS OF THE REMAINING CORNEA. BOTH CASES CLEARLY DEMONSTRATE IMPROPER ASSEMBLY OF CO'S DEVICE BY THE TECHNICIAN LEADING TO DEEPER THAN NORMAL CUTS INTO THE CORNEA. IN ANY OTHER INCIDENT OF THIS NATURE, PROCEDURE WOULD BE TO REPLACE THE CORNEAL FLAP WITHOUT PROCEEDING WITH USE OF THE EXCIMER. THIS DID NOT OCCUR IN EITHER INCIDENT. CO HAS RECENTLY COMPLETED AN EXTENSIVE REVIEW OF FDA GUIDELINES. UPON REVIEW OF THE FIRST EVENT, CO DETERMINED A "CONTRIBUTORY FACTOR" IN SUCH AN INCIDENT MUST BE CONSIDERED DESPITE THE OPERATOR ERROR ASPECT, AND AS SUCH SHOULD BE REPORTED. NO H3 REFERENCE IS GIVEN AS DEVICE EVALUATION WAS NOT DEEMED NECESSARY.