ALCON MICROSURGICAL INSTRUMENTS, CANNULA OPHTHALMIC

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 NON-HEALTHCARE PROFESSIONAL REPORTED THAT SILICONE TIP WAS DETACHED FROM THE CANNULA DURING SURGERY. PROCEDURE WAS COMPLETED ON THE SAME DAY. PATIENT HARM WAS NOT REPORTED.