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

Additional Manufacturer Narrative

ADDITIONAL INFORMATION PROVIDED IN D.9., H.3., H.6., AND H.11. THE RETURNED PRODUCT WAS VISUALLY INSPECTED, AND 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 BLACK RADIOFREQUENCY IDENTIFICATION (RFID) CONNECTOR DID NOT LIGHT. THE RETURNED SYRINGE AND PLUG WERE ENGAGED TO THE ADAPTER. THE LIGHT EMITTING DIODE (LED) RING ON THE CONSOLE DID NOT TURN GREEN AS THE RFID CONNECTORS WERE CONNECTED TO THE CONSOLE, SHOWING THE COMMUNICATION FAILURE BETWEEN THE VFC CONNECTOR AND THE CONSOLE. WHEN ACTIVATING THE FOOTSWITCH IN THE EXTRUSION / INJECTION CONTROL IN VFC MODE, A SYSTEM MESSAGE CODE 1214 APPEARED ON THE CONSOLE SCREEN STATING, "SYSTEM HASN'T DETECTED VFC. THE INVESTIGATION CONDUCTED A NON-CONFORMANCE REVIEW OF THE REPORTED LOT NUMBER. NO DEVIATIONS THAT COULD HAVE CONTRIBUTED TO THIS EVENT WERE IDENTIFIED AND ALL CORRESPONDING PRODUCTION RELEASE SPECIFICATIONS DEFINED IN THE DEVICE MASTER RECORD WERE MET. THE MISSING RFID CHIP WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE CUSTOMER'S REPORTED EVENT. THE MISSING RFID CHIP IS RELATED TO AN ERROR DURING THE SUPPLIER'S ASSEMBLY PROCESS. THE SUPPLIER WAS NOTIFIED OF THIS COMPLAINT AND ISSUE. ACTION WILL NOT BE TAKEN BASED ON THIS OCCURRENCE. THE SUPPLIER HAS BEEN MADE AWARE OF THE ISSUE. QUALITY ASSURANCE WILL CONTINUE TO MONITOR AND WILL TAKE ACTION FOR FUTURE OCCURRENCES AS DEEMED NECESSARY. CONSUMABLES MANUFACTURING HAS ALSO BEEN MADE AWARE OF THE ISSUE THROUGH THE MONTHLY COMPLAINT REVIEW MEETING. 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).

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 SYSTEM PROMPTED, THE TUBING WAS NOT CONNECTED WHEN TRYING TO EXTRACT OIL, THE OIL EXTRACTION OPERATION CANNOT BE COMPLETED DURING VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED BY REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO PATIENT IMPACT.