UNITY CATARACT FMS PROCEDURE PACK

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.

Description of Event or Problem

A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING SURGERY, THE ASPIRATION TUBING OF AN OPHTHALMIC HANDPIECE WAS NOT SECURED WITH A SCREW AND COULD BECOME DETACHED DURING THE CORTEX REMOVAL STAGE. THE PROCEDURE TYPE AND OTHER SURGERY DETAILS WERE UNKNOWN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT. THIS REPORT PERTAINS TO THE SUCTION TUBING INVOLVED IN THE COMPLAINT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NON-RECEIVED TILL DATE.