AGE/DATE OF BIRTH: UNKNOWN/ NOT PROVIDED. (B)(6). (B)(4). DEVICE EVALUATION THE FEMTOSECOND LASER MACHINE WAS EXAMINED AND TESTED AT THE CUSTOMER LOCATION BY AN JJSV FIELD SERVICE SPECIALIST (FSS). THE FSS CHECKED GEL AT SURGERY SETTINGS. 80 PERCENT MELT. EASY LIFT. THE FSS PERFORMED A FIELD SERVICE CHECKLIST. THE SYSTEM WAS VERIFIED FOR ALL MODES OF OPERATIONS. THE SYSTEM MET JJSV SPECIFICATIONS. A REVIEW OF RECORDS RELATED TO THE DEVICE INCLUDING LABELING, COMPLAINT TRENDING, AND RISK DOCUMENTATION WILL BE PERFORMED. UPON COMPLETION OF THIS REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.
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Patient 1
IT WAS REPORTED THAT A LASER VISION CORRECTION PATIENT EXPERIENCED A FREE FLAP ON THE PATIENT?S RIGHT OPERATIVE EYE ON TREATMENT DATE (B)(6) 2020. A DESCRIPTION OF THE EVENT IS THE SURGEON ENCOUNTERED A FREE FLAP ON THE PATIENT RIGHT EYE WHILE LIFTING FLAP. HE REPLACED THE FLAP AND ALIGNED INTO POSITION AFTER COMPLETING EXCIMER LASER. ROUTINE POST-OP DROPS AND BCL PRESCRIBED POST-OP. AT A ONE-DAY POST OP EXAM, THE SURGEON NOTED EPITHELIAL ABRASION ON THE RIGHT EYE (RE), HOWEVER HAD A GOOD FLAP EDGE. IT WAS ALSO NOTED THE LEFT EYE (LE) HAD EPITHELIAL ABRASION OUTSIDE THE FLAP EDGE WITH GOOD FLAP EDGES. ADDITIONALLY, IT WAS REPORTED THE SURGEON IS NEW TO USING THE LASER EQUIPMENT. UCVA AT ONE DAY POST OP. RE 6/7.5 LE 6/7.5.