ADDITIONAL INFORMATION: DATE OF EVENT: BETWEEN 12/16/2019 TO 2/18/2020. EXPLANTED, GIVE DATE: NOT APPLICABLE AS LENS HAS NOT BEEN EXPLANTED. (B)(4). DEVICE EVALUATION: PRODUCT TESTING COULD NOT BE PERFORMED AS THE PRODUCT WAS NOT RETURNED. THE REPORTED COMPLAINT COULD NOT BE VERIFIED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. A SEARCH REVEALED THAT NO SIMILAR COMPLAINTS WERE RECEIVED FOR 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 A ZLB00 INTRAOCULAR LENS (IOL) 20.0 DIOPTER WAS IMPLANTED IN THE PATIENT?S RIGHT EYE AND A ZKB00 20.0 WAS IMPLANTED IN THE LEFT EYE. THE PATIENT IS EXPERIENCING HALOS, BLURRY VISION AND STARBURSTS. PER THE PATIENT, HE WAS TOLD AT THE DOCTOR?S OFFICE BEFORE THE SURGERIES THAT HE?D HAVE THE EYESIGHT OF A 20-YEAR OLD. HOWEVER, AFTER SURGERY, PATIENT IS EXPERIENCING HALOS, BLURRED VISION AND STARBURSTS. HE?S ALSO HAVING DIFFICULTY WHILE DRIVING AT NIGHT. THE SIGN POSTS LOOK TWICE THEIR ACTUAL SIZE. THE PATIENT IS NOT TAKING ANY EYE DROPS. THRU FOLLOW-UP THE PATIENT REPORTED HE HAD FLOATERS PRIOR TO THE IMPLANTS. HE STILL HAS FLOATERS POST IMPLANTS BUT NOW THE FLOATERS ARE WORSE. HE CLARIFIED, HE IS HAVING THE SAME SYMPTOMS IN BOTH EYES. THE LEFT EYE IS JUST WORSE. NO FURTHER INFORMATION WAS PROVIDED. THIS MDR WILL CAPTURE INFORMATION FOR THE RIGHT EYE IOL ZLB00. THE LEFT EYE IS CAPTURED IN A SEPARATE MDR.