INTREPID COAXIAL POLYMER CONICAL DISPOSABLE I/A HANDPIECE

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 DURING CATARACT SURGERY WITH INTRA OCULAR LENS IMPLANTATION, AN OPHTHALMIC IRRIGATION AND ASPIRATION HANDPIECE HAD NO ASPIRATION. INITIALLY TRIED CHANGING THE (IRRIGATION AND ASPIRATION) I/A HANDPIECE BUT THAT DID NOT WORK, THEN CHANGED THE ENTIRE CARTRIDGE AND WERE THEN ABLE TO REGAIN SUCTION DURING THE CASE AND THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT IMPACT.