NON-ABSORBABLE SURGICAL SUTURES

Description of Event or Problem

ADVERSE EVENT: "POST-OPERATIVE INFLAMMATION" (INFLAMMATION). PRODUCT PROBLEM: "UNKNOWN" (NO CODE AVAILABLE). THE FACILITY REPORTED PTS EXPERIENCED POST OPERATIVE INFLAMMATION (NUMBER OF PTS NOT SPECIFIED). FOUR TO SIX WEEKS AFTER UNCOMPLICATED PHACOEMULSIFICATION SURGERIES. ONE OF THE PTS RETURNED WITH A SUSPECTED INFECTION ENDOPHTHALMITIS BUT CULTURES PERFORMED SHOWED NO GROWTH. PTS HAD RED AND SWOLLEN EYES WITH SOME DISCOMFORT BUT NO PAIN. PTS WERE GIVEN STEROIDAL TREATMENT AND THE EVENTS RESOLVED. HOWEVER, EVEN THE POST-OPERATIVE INFLAMMATION HAD RESOLVED, THE HOSPITAL COULD NOT ASSURE THAT THE POST-OPERATIVE INFLAMMATION WAS TRANSIENT. THE SURGERIES WERE PERFORMED FROM THE MIDDLE OF JANUARY TO THE END OF MARCH. THERE WERE 6 OTHER SURGEONS OPERATING AT THIS FACILITY. ONLY ONE SURGEON HAD A SIGNIFICANT NUMBER OF CASES AND WAS THE ONLY ONE WHO USED ALCON SUTURES. ANOTHER SURGEON HAD A SIMILAR CASE AFTER IMPLANTATION OF AN IOL (INTRAOCULAR LENS). THE FACILITY IS INVESTIGATING THE POSSIBLE CAUSE OF THE INFLAMMATION. ADD'L INFO HAS BEEN REQUESTED.

Additional Manufacturer Narrative

INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B) (4). (B) (4). (B) (4).