UNIVERSAL VISCOUS FLUID CONTROL PACK

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED AND IT WAS CONFIRMED THE TIP HAD SEPARATED FROM THE BODY OF THE CANNULA. AS THE LOT NUMBER IS UNKNOWN, VISUAL INSPECTION AND MAGNETIC ATTRACTION WERE USED TO IDENTIFY MATERIAL AND MANUFACTURING METHOD USED TO PRODUCE PART. TOOLING MARKS AND MAGNETIC ATTRACTION INDICATE THAT THIS CANNULA WAS MACHINED FROM 304 STAINLESS STEEL (MAGNETIC). THIS MATERIAL AND PROCESS ARE NO LONGER USED TO PRODUCE THESE PARTS. CURRENT PARTS ARE DEEP DRAWN FROM 305 STAINLESS STEEL (NONMAGNETIC). THIS IS THE FIRST COMPLAINT OF THIS TYPE REPORTED AND COMPLAINT HISTORY DID NOT REVEAL ANY NEGATIVE QUALITY PATTERNS. THE TREND ANALYSIS, RISK ANALYSIS AND DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. NO CORRECTIVE ACTION REQUIRED. BASED ON ALL AVAILABLE INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED AND NO CONCLUSION CAN BE DRAWN. THE INVESTIGATION IS COMPLETE.

Additional Manufacturer Narrative

ALTHOUGH REQUESTS HAVE BEEN MADE, THE DEVICE HAS YET TO BE RETURNED. THE LOT NUMBER IS NOT KNOWN, SO A DHR REVIEW WAS NOT POSSIBLE AT THIS TIME. IT WAS REPORTED THERE WAS NO CLINICAL CONSEQUENCE. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

A USER FACILITY IN FRANCE INDICATED THAT WHILST PERFORMING RETINAL SURGERY, WITHOUT FORCE, THE METAL TIP OF THE CANNULA BROKE OFF AND FELL ONTO THE PATIENT¿S MACULA, INTO THE PATIENT'S EYE. THE SURGEON USED A TROCAR TO INSERT A BL7600 SYRINGE. DURING DK-LINE /SILICONE EXCHANGE, THE SURGEON SUCCEEDED IN REMOVING THE TIP OF CANNULA WITH A MAGNETIC CLAMP, WHICH NECESSITATED INCREASING THE INCISION SIZE TO 18G. AT THIS TIME, THE LOT NUMBER IS UNKNOWN.