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 RUBBER SIZE DID NOT FIT DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANT. SURGERY WAS COMPLETED AFTER BEING REPLACED WITH THE SAME 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 USED VISCOUS FLUID CONTROL (VFC) TUBING SET, 10 MILLILITER (ML) SYRINGE AND SMALL PART TRAY CONTAINING THE CANNULAS WERE RETURNED. THE RETURNED PRODUCT WAS VISUALLY INSPECTED. IN RETURN CONDITION, THE GRAY TIP PLUNGER WAS INSIDE THE SYRINGE. THE 25 GAUGE (GA), 23GA AND 20GA VFC CANNULA NEEDLE TIPS COULD FULLY ENGAGE WITH THE 10ML SYRINGE. THE VFC TUBING SET AND GRAY TIP PLUNGER COULD FIT INTO THE 10ML SYRINGE. THE VFC TUBING SET, 10ML SYRINGE, GRAY TIP PLUNGER, 25GA, 23GA AND 20GA VFC CANNULA NEEDLE TIPS WERE OBSERVED TO BE IN GOOD CONDITION. THE VFC TUBING SET WAS TESTED USING THE CONSOLE. THE LIGHT EMITTED DIODE (LED) RINGS ON THE CONSOLE TURNED GREEN AS THE RADIO FREQUENCY IDENTIFICATION (RFID) CONNECTOR WAS ENGAGED TO THE CONSOLE INDICATING PROPER COMMUNICATION BETWEEN THE CONNECTOR AND THE CONSOLE. THERE WERE NO "FIT" ISSUES OBSERVED DURING EVALUATION. WE WERE UNABLE TO REPLICATE THE CUSTOMER'S EXPERIENCE DURING LABORATORY EVALUATION. 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 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).