UNIVERSAL VISCOUS FLUID CONTROL PACK

Additional Manufacturer Narrative

THE PRODUCT HAS BEEN REQUESTED. THIS INVESTIGATION IS ONGOING.

Description of Event or Problem

THE USER FACILITY IN FRANCE REPORTED THAT DURING THE INJECTION OF SILICONE OIL INTO THE PATIENT'S EYE, A POPPING NOISE WAS HEARD WHICH INTERRUPTED THE SURGERY. UPON THE SURGICAL TEAM'S INSPECTION, IT WAS NOTICED THAT THE FILTER OF THE SILICONE INJECTION LINE WAS HALF MISMATCHED. THE SURGEON SUBSEQUENTLY OBSERVED A CHOROIDAL HEMATOMA EXTENDING TO 1/3 OF THE TEMPORAL SURFACE DURING THE FUNDUS EXAMINATION. A DISCHARGE SCLEROTOMY WAS PERFORMED TO ATTEMPT TO EVACUATE THE HEMATOMA, HOWEVER IT WAS WITHOUT SUCCESS. THERE WERE ALSO POTENTIALLY SIGNIFICANT CLINICAL CONSEQUENCES WITH AN ANATOMICAL AND FUNCTIONAL PROGNOSIS RESERVED. THERE WAS NO ADDITIONAL ANESTHESIA REQUIRED FOLLOWING THE ISSUE. NO ADDITIONAL MEDICAL INTERVENTION IS PLANNED TO TREAT CHOROIDAL HEMATOMA. REASSESSMENT OF THE PATIENT'S VISION CONCLUDED THAT IT HAS NOT IMPROVED COMPARED WITH VISION BEFORE THE SURGERY.

Additional Manufacturer Narrative

CORRECTION: H6 TYPE OF INVESTIGATION FROM: 4114 TO: 10, 4109, 4110, 4112.

Additional Manufacturer Narrative

PALL'S EXTENSIVE EVALUATION OF THE RETURNED FILTER FOUND NO EVIDENCE OF COMPONENT DAMAGE ON EITHER 25MM PORT HOUSINGS. THE MAJOR MEMBRANE SHOWED NO GROSS SIGNS OF DAMAGE OR MISSING MATERIAL FROM FIELD USE. THE FILTER WAS FOUND TO HAVE NORMAL WELDING EVIDENCE ON BOTH 25MM PORT HOUSINGS. THEY WERE UNABLE TO DETERMINE AN EXACT ROOT CAUSE. 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 IS REQUIRED.

Additional Manufacturer Narrative

PRODUCT EVALUATION CONFIRMED THE FAILURE MODE THAT THE FILTER HOUSING HAS PARTIALLY OPENED AT THE SEAM. THE PRODUCT WAS SENT TO ESCALON, THE VENDOR, AND THEIR EVALUATION ALSO DETERMINED THAT THE FILTER MEMBRANE WAS PARTIALLY DISCONNECTED FROM THE FILTER HOUSING. THE HOUSING WAS NOT CRACKED OR DAMAGED AND THERE WAS NO APPARENT DAMAGE TO THE MEMBRANE FILTER. THEY WERE ABLE TO REPRODUCE THE "POP" NOISE WHEN DETACHING THE FILTER MEMBRANE FROM THE HOUSING. THE INCOMING PALL FILTERS ARE INSPECTED BY ESCALON BEFORE ASSEMBLY AND NO ABNORMALITIES OR DEFECTS WERE DETECTED. THE FILTER HAS BEEN SENT TO PALL FOR THEIR EVALUATION. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED: THEREFORE ROOT CAUSE HAS NOT BEEN ESTABLISHED AT THIS TIME. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

ADDITIONAL INFORMATION RECEIVED EXPLAINED THE SYRINGE CONTAINING SILICONE OIL WAS CONNECTED TO STELLARIS SYSTEM WITH A COMBINED PACK 23 GA. THE MISMATCHING OF THE DEVICE OCCURRED AT THE LEVEL OF THE BLEU FILTER (PARTIAL MISMATCHING).