(B)(4). FSE ON SITE COMPLETED THE FOLLOWING: VIEWED ALL TECHNICIANS THAT UTILIZED THE IDESIGN DURING THE CAPTURE SEQUENCE. COMPLETED IDESIGN CLINICAL OPTIMIZATION CHECKLIST. ASM DISCUSSED OUTCOMES WITH THE TLC ACCOUNT REGIONAL DIRECTOR, CLINIC DIRECTOR AND THE PHYSICIAN. IT WAS FOUND THAT THE PHYSICIAN PLANNED ALL TREATMENTS AND THE NOMOGRAM USED WAS GLEANED FROM A DIFFERENT TLC SITE IN (B)(6). TWO OTHER PHYSICIANS MENTIONED THAT THE PHYSICIAN REPORTING THE ISSUES COMES IN (TO THE CENTER) AND STEPS INTO THE FOOTPEDAL. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.
D
Patient 1
THE CLINIC REPORTED THAT A LASER VISION CORRECTION PATIENT HAD SURGERY ON (B)(6) 2017 AND PRESENTED ON 1 DAY POST-OP WITH AN ASTIGMATISM IN BOTH EYES. IT WAS STATED THAT THE PATIENT HAD A LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA).? BCVA: RIGHT EYE PRE-OP 20/20 2.25 X -4.50 X 180, LEFT EYE PRE-OP 20/20 1.25 X -3.50 X 3. BCVA 1 DAY POST-OP: RIGHT EYE POST-OP 20/30 -1.75 X -.75 X 102, LEFT EYE POST-OP 20/30 -.50 X -.50 X 93. THIS REPORT IS FOR THE IDESIGN ABERROMETER. A SEPARATE REPORT IS BEING SUBMITTED FOR THE EXCIMER LASER.
N
Patient 1
INITIALLY REPORTED DEVICE MANUFACTURING DATE FROM 11/1/2016 TO CORRECTED DEVICE MANUFACTURING DATE AUGUST 2016. DEVICE EVALUATION: A REVIEW OF THE RECORDS RELATED TO THE DEVICE THAT INCLUDED LABELING, MANUALS, TRENDING, AND RISK DOCUMENTATION WAS PERFORMED. THE TREND REVIEW SHOWS THAT THERE IS NOT SIGNIFICANT CHANGE OVER HISTORICAL COMPLAINT LIMITS AND NO RECOGNIZABLE ADVERSE TREND. THE RISKS AND MITIGATIONS ASSOCIATED WITH THE COMPLAINT ISSUE ARE IDENTIFIED IN EXISTING RISK DOCUMENTS AND NO NEW RISKS WERE IDENTIFIED AS PART OF THIS INVESTIGATION. THERE WAS NO PRODUCT DEFICIENCY IDENTIFIED. THE REVIEW OF THE DEVICE HISTORY RECORD (DHR) THE REFRACTIVE IDESIGN SHOWED THAT THERE WERE NO ISSUES OR NON-CONFORMITIES. MANUFACTURING HAS BEEN RULED OUT AS A POTENTIAL CAUSE FOR THE REPORTED ISSUE. NO CONCLUSIVE EVIDENCE IDENTIFIED FOR REPORTED ISSUE. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.