VISCOUS FLUID CONTROL TUBING SET (SILICONE OIL INJ/EXT)

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 ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

Description of Event or Problem

A NURSE REPORTED THAT SILICON OIL TUBING RUPTURED DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING WITH NEW PRODUCT. THERE WAS NO PATIENT IMPACT.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION PROVIDED IN D.9., H.2., H.3., H.6. AND H.11. THE RETURNED PRODUCT WAS VISUALLY INSPECTED, AND NO OBVIOUS DEFECTS WERE OBSERVED. A CALIBRATED CONSOLE WAS USED TO TEST THE SAMPLE. THE CONSOLES COULD RECOGNIZE THE VISCOUS FLUID CONTROL (VFC) BY ILLUMINATING GREEN ON THE LIGHT EMITTED DIODE (LED) RING. THE VFC SAMPLE WAS FILLED WITH SILICONE OIL PER DIRECTIONS FOR USE (DFU); IN INJECTION MODE THE PLUNGER MOVED FREELY AND MET SPECIFICATIONS. EXTRACTION MODE WAS THEN SELECTED AND THE VFC COULD ASPIRATE SILICONE OIL INTO THE BARREL OF THE SYRINGE; NO ANOMALIES WERE OBSERVED DURING THIS STEP. PRESSURE WAS STABLE DURING FUNCTIONAL TESTING. THE PLUNGER IN THE SYRINGE MOVED SMOOTHLY DURING OPERATION. ADDITIONALLY, ALL CONNECTIONS WERE FOUND TO FIT SECURELY. WE WERE UNABLE TO REPLICATE THE CUSTOMER'S EXPERIENCE. THERE WAS NO SILICONE OIL RUPTURE OBSERVED DURING LABORATORY TESTING. THE INVESTIGATION CONDUCTED A NON-CONFORMANCE REVIEW OF THE REPORTED LOT NUMBER. NO DEVIATION WAS IDENTIFIED THAT WOULD HAVE CONTRIBUTED TO THIS EVENT AND ALL CORRESPONDING PRODUCTION RELEASE SPECIFICATIONS DEFINED IN THE DEVICE MASTER RECORD WERE MET. BASED ON THE EVALUATION OF THE INFORMATION AND MATERIALS RECEIVED, THE INVESTIGATION WAS UNABLE TO IDENTIFY THE ROOT CAUSE OR ORIGIN OF THE REPORTED EVENT AS THE PRODUCT FUNCTIONED PER SPECIFICATIONS. ADDITIONALLY, NO MANUFACTURING-RELATED DEFICIENCIES WERE FOUND THAT POTENTIALLY COULD HAVE CONTRIBUTED TO THE COMPLAINT. BASED ON THE EVALUATION OF THE INFORMATION AND MATERIALS RECEIVED, THE INVESTIGATION WAS UNABLE TO IDENTIFY THE ROOT CAUSE OR ORIGIN OF THE REPORTED EVENT. ADDITIONALLY, NO MANUFACTURING-RELATED DEFICIENCIES WERE FOUND THAT POTENTIALLY COULD HAVE CONTRIBUTED TO THE COMPLAINT, THEREFORE NO ACTION WILL BE TAKEN FOR THIS OCCURRENCE. COMPLAINT DATA FOR ALL COMPANY PRODUCTS IS REVIEWED MONTHLY TO MONITOR FOR ADVERSE TRENDS. DURING THE LAST REVIEW, NO ADVERSE TRENDS WERE OBSERVED FOR THE REPORTED PRODUCT AND EVENT COMBINATION. QUALITY ASSURANCE HAS REVIEWED THIS COMPLAINT AND WILL CONTINUE TO MONITOR DATA FOR EVIDENCE OF ADVERSE TRENDING AND TAKE FURTHER ACTION, AS APPROPRIATE. NO FURTHER ACTION WARRANTED AT THIS TIME. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).