ISPAN C3F8 INTRAOCULAR GAS

Additional Manufacturer Narrative

ONE TR9089 ALUMINUM CYLINDER (C3F8) WITH VALVE FROM LOT NUMBER 435802 WAS RETURNED. THE EXPIRATION DATE ON THE LABEL WAS 2026-NOV-30. HOWEVER, THE CYLINDER WAS RETURNED IN A BOX LABELED LOT 435809 WITH AN EXPIRATION DATE 2026-NOV-30. THE PRODUCT EVALUATION WILL BE PERFORMED BY THE VENDOR. THE STERILIZATION AND LOT HISTORY RECORDS WERE REVIEWED AND FOUND TO BE ACCEPTABLE. THE LOT HISTORY, TREND ANALYSIS, RISK ANALYSIS AND/OR DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. NO CORRECTIVE ACTION REQUIRED.

Additional Manufacturer Narrative

THE MANUFACTURER'S EVALUATION RESULTS WERE RECEIVED. IT STATED, A CHECK OF THE COMPLAINT RECORDS SHOWED NO OTHER COMPLAINTS AGAINST LOT 435802. A CHECK FOR COMPLAINTS OF RAPID DISSOLUTION OF C3F8 IN THE EYE AFTER A PROCEDURE SHOWED NO CONFIRMED COMPLAINTS SINCE 2018. AN ANALYSIS OF THE RETAIN SAMPLE FROM THE SAME MASTER PRODUCTION LOT CONFIRMED THAT THE PRODUCT WAS PFP AND MET ALL RELEASE CRITERIA. AN ANALYSIS OF THE RETURNED PRODUCT CONFIRMED THAT IT MEET ALL SPECIFICATIONS. CONCENTRATION WAS 99.89% PFP. NOTHING WAS FOUND THAT WOULD ACCOUNT FOR THE REPORTED EVENT. ROOT CAUSE OF COMPLAINT COULD NOT BE DETERMINED FROM INVESTIGATION.

Description of Event or Problem

THE USER FACILITY ENCOUNTERED A VITRECTOMY CASE WHERE A PATIENT RETURNED THE FOLLOWING DAY WITH ONLY APPROXIMATELY 20% OF THE C3F8 GAS REMAINING IN THE EYE. THERE HAVE BEEN NO CHANGES TO THE PROCEDURE FOR DRAWING UP OR ADMINISTERING THE GAS, AND ALL PROTOCOLS WERE FOLLOWED AS USUAL WITH 8 CC C3F8 GAS WITH 52 CC ROOM AIR. GIVEN THESE CONCERNS, THEY HAVE TAKEN THE CURRENT CANISTER OUT OF SERVICE AS A PRECAUTION. THERE WAS NO TRAUMA TO THE PATIENTS EYE; HOWEVER, THE PATIENT RETURNED TO OR FOR REPEAT RETINAL DETACHMENT REPAIR DUE TO POOR GAS FILL WITH RAPID DISSOLUTION OF C3F8 GAS.

Additional Manufacturer Narrative

THIS INVESTIGATION IS ONGOING.