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 PHYSICIAN REPORTED THAT THE STICK DID NOT GO INTO THE SYRINGE DURING VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED BY REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO PATIENT IMPACT.

Additional Manufacturer Narrative

THE RETURNED PRODUCT WAS VISUALLY INSPECTED AD NO OBVIOUS DEFECTS WERE CONFIRMED. THE GRAY PLUNGER WAS FOUND AT THE BOTTOM OF THE SYRINGE BARREL. SILICONE OIL WAS OBSERVED ON THE CANNULAS. A CONSOLE, REPRESENTING CURRENT SOFTWARE VERSIONS WAS USED TO TEST THE VISCOUS FLUID CONTROL (VFC) TUBING. THE SYRINGE WAS CONNECTED TO THE ADAPTER AND COULD FULLY ENGAGE. THE SYRINGE SEATED IN THE ADAPTER AND THE CANNULA¿S SEATED ON THE SYRINGE LUER LOCK BARB FIRMLY AND SECURELY. THE LIGHT EMITTING DIODE (LED) RINGS ON THE CONSOLE TURNED GREEN AS THE GRAY CONNECTOR WAS ENGAGED TO THE CONSOLE INDICATING THE PROPER COMMUNICATION BETWEEN THE CONNECTOR AND THE CONSOLE. THE CANNULA DID NOT POP OFF DURING FUNCTIONAL TESTING. PRESSURE WAS STABLE DURING FUNCTIONAL TESTING. THE PLUNGER IN THE SYRINGE MOVED SMOOTHLY DURING OPERATION. THE INVESTIGATION CONDUCTED A NON-CONFORMANCE REVIEW OF THE REPORTED LOT NUMBER. NO DEVIATIONS WERE IDENTIFIED 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. ADDITIONALLY, NO MANUFACTURING-RELATED DEFICIENCIES WERE FOUND THAT POTENTIALLY COULD HAVE CONTRIBUTED TO THE COMPLAINT. NO FURTHER INVESTIGATIVE OR MANUFACTURING ACTIONS ARE WARRANTED AT THIS TIME DUE TO THE PRODUCT MEETING SPECIFICATIONS. RECEIPT OF ADDITIONAL RELEVANT INFORMATION OR SUPPORTING MATERIALS WILL PROMPT A RE-EVALUATION OF THE COMPLAINT INVESTIGATION. COMPLAINT DATA FOR ALL 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).