ALCON MICROSURGICAL INSTRUMENTS, CANNULA OPHTHALMIC

Description of Event or Problem

A NURSE REPORTED THAT AN OPHTHALMIC CANNULA WAS GETTING STUCK IN THE TROCAR, CAUSING THE TROCAR TO DISENGAGE FROM THE SCLERA. THE PROCEDURE WAS COMPLETED THE SAME DAY USING A NEW CANNULA. THERE WAS NO PATIENT IMPACT.

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).