CONSTELLATION SURGICAL 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).

Description of Event or Problem

A PHYSICIAN REPORTED THAT THE CASSETTE LEAKED DURING VITRECTOMY SURGERY. AFTER REMOVING THE CASSETTE, IT WAS FOUND THAT THE IRRIGATION CHAMBER HAD RUPTURED. THE PROCEDURE WAS COMPLETED ON SAME DAY AFTER REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO PATIENT IMPACT.