THE DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION FOUND THAT THE LENS IS IN TWO PIECES. THE OPTIC WAS CUT OR TORN IN HALF. ONE HAPTIC PLATE WITH ARMS WAS ATTACHED TO EACH SIDE OF THE RETURNED OPTIC. A DEVICE HISTORY RECORD (DHR) REVIEW DID NOT FIND ANY NONCONFORMITIES OR ANOMALIES RELATED TO THIS COMPLAINT. BASED ON THE AVAILABLE INFORMATION, A ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. THIS REPORT IS FOR THE SECOND EXPLANTED CRYSTALENS IOL DESCRIBED IN THE EVENT NARRATIVE. A REPORT FOR THE FIRST EXPLANTED CRYSTALENS IOL WAS ALSO SUBMITTED UNDER REPORT NUMBER 0001313525-2018-00147.
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Patient 1
IT WAS STATED THAT A CRYSTALENS INTRAOCULAR LENS (IOL), WHICH WAS IMPLANTED IN THE RIGHT EYE, WAS USED AS A REPLACEMENT TO ANOTHER MANUFACTURER'S LENS. WITH THE OTHER MANUFACTURER'S LENS, THE PATIENT WAS SAID TO HAVE EXPERIENCED HALOS AND GLARE. NEARLY 3 MONTHS POST-IMPLANT OF THE CRYSTALENS IOL, THE PATIENT WAS REPORTED TO HAVE EXPERIENCED Z-SYNDROME. FOLLOWING THE EXPLANT OF CRYSTALENS IOL (SERIAL NUMBER ENDING IN (B)(4)), THE PATIENT EXPERIENCED Z-SYNDROME ONCE MORE WITH A SECOND CRYSTALENS IOL (SERIAL NUMBER ENDING IN (B)(4)) AFTER JUST ONE WEEK. AS A RESULT, CRYSTALENS IOL (SERIAL NUMBER ENDING IN (B)(4)) WAS ALSO EXPLANTED AND REPLACED WITH A LENS OF A DIFFERENT MODEL. THE SURGEON ATTRIBUTED THE RECURRING Z-SYNDROME TO CAPSULAR CONTRACTION. REGARDING PROGNOSIS, THE PATIENT IS SAID TO BE HAPPY AND SEEING WELL.