(B)(4). FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE EVENTS OF FIBROSIS, KERATITIS, DEVICE MIGRATION, VISION LOSS, HIGH INTRAOCULAR PRESSURE AND CONJUNCTIVAL HYPERTHERMIA ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN INITIATED. IF ANY NEW, CHANGED OR CORRECTED INFORMATION IS NOTED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.
D
Patient 1
HEALTHCARE PROFESSIONAL PATIENT WITH A XEN 45 GEL STENT IN THE LEFT EYE HAS NEED SEVERAL NEEDLINGS DUE TO A TENSION RESULT UNSATISFACTORY. IN A GONIOSCOPY, THE XEN IMPLANT IS FOUND ON THE LEFT SIDE IN AN INTRA-CAMERAL AND PROBABLY INTRA-SCLERAL POSITION AND THE DISTAL END IS NO LONGER IN A SUB-CONJUNCTIVAL POSITION PROBABLY DUE TO SIGNIFICANT FIBROSIS AND PROGRESSIVE SLIPPING OF THE DEVICE. IT WAS NOTED "THE IMPLANT IS TROUBLESOME, LEADS TO A DECREASE OF THE VISION AND ENDOTHELITIS." UNDER LOCAL ANESTHESIA, "DECISION TO REMOVE THE XEN BECAUSE MALPOSITION IN ANTERIOR CHAMBER WITH MARKED CONJUNCTIVAL HYPERHEMIA AND REALIZATION OF A DEEP FILTERING SCLERECTOMY. NO INTRA- OR POST-OPERATIVE COMPLICATIONS.?