IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS REMAINS IMPLANTED. (B)(4) DEVICE EVALUATION: PRODUCT TESTING COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED AS LENS REMAINS IMPLANTED. THE COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING PROCESS RECORD WAS EVALUATED AND REVEALED THAT THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. A SEARCH REVEALED THAT NO SIMILAR COMPLAINTS WERE RECEIVED FROM THIS PRODUCTION ORDER. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.
D
Patient 1
IT WAS REPORTED THAT CLINICAL STUDY PATIENT UNDERWENT BILATERAL INTRAOCULAR LENS (IOL) IMPLANTS. AT 1 MONTH VISIT HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS VERY BOTHERED BY HALOS, VERY DISTRACTIVE IN BUILDINGS; EXTREMELY BOTHERED BY STARBURSTS, HAD SAFETY CONCERNS WITH DRIVING; EXTREMELY BOTHERED BY MULTIPLE OR DOUBLE VISION, TOTALLY DISABLING WHEN IT OCCURS; VERY BOTHERED BY GLARE, DRIVING; MODERATELY BOTHERED BY POOR LOW LIGHT VISION, NUISANCE. PREOPERATIVE VISUAL ACUITY: BEST CORRECTED DISTANCE VISUAL ACUITY (BCVA), RIGHT EYE (OD) 20/20; LEFT EYE (OS) 20/20 THE MONOCULAR UNCORRECTED DISTANCE VISUAL ACUITY (UCDVA) ? OD 20/25; OS 20/25. MONOCULAR BCDVA ? OD 20/15; OS 20/15. ON OCULAR EXAM POSTERIOR CAPSULE OPACIFICATION (PCO)- BOTH EYES, WAS NOTED. THE SUBJECT IS SCHEDULED TO HAVE A YTTRIUM ALUMINUM GARNET (YAG) CAPSULOTOMY FOR THE POSTERIOR CAPSULE OPACIFICATION (PCO- LASER TREATMENT) IN 1 WEEK FOR THE OD AND 3 WEEKS FOR THE OS. IT WAS LEARNT THAT THE SUBJECT HAD YAG OF OD ON (B)(6) 2020. THEN ON (B)(6) 2020 ANOTHER YAG FOR THE OS. THE PATIENT VISUAL ACUITY IS UNKNOWN AT THIS TIME. NO OTHER INTERVENTION IS PLANNED. NO FURTHER INFORMATION AVAILABLE. THIS MDR REPORT PERTAINS TO THE LEFT EYE (OS). A SEPARATE REPORT WILL BE SUBMITTED FOR THE RIGHT EYE (OD).