SILICONE IRRIGATION AND ASPIRATION TIPS

Description of Event or Problem

A NURSE REPORTED THAT PATIENT EXPERIENCED ENDOPHTHALMITIS POST CATARACT AND VITRECTOMY COMBINATION SURGERY. SURGEON REPORTED THAT USAGE OF IRRIGATION AND ASPIRATION TIP, VISCOELASTICS, INSTRUMENT TRAY, HANDPIECE, FORCEPS, SILICON OIL, LASER PROBE, DIATHERMY PROBE AND GAS DURING THE SURGERY. THERE WAS NO INFORMATION ABOUT CURRENT PATIENT¿S CONDITION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS RECEIVED TILL DATE. THIS REPORT PERTAINS TO ONE OF THE TWO PATIENTS EXPERIENCING ENDOPHTHALMITIS REPORTED FROM SAME FACILITY. THIS REPORT IS PERTAINING TO OPHTHALMIC IRRIGATION AND ASPIRATION TIP (IA TIP).

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). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.