CONSTELLATION SURGICAL PROCEDURE PACK

Description of Event or Problem

A NON-HEALTHCARE PROFESSIONAL REPORTED THAT OCUTOME¿S CUTTING FUNCTION WAS NOT OPERATING; ONLY VACUUM FUNCTION WAS WORKING AT UNKNOWN TIMING OF VITRECTOMY SURGERY. THE SURGERY COMPLETION DETAILS WERE UNKNOWN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT. ADDITIONAL INFORMATION WAS REQUESTED AND NON-RECEIVED TILL DATE.

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).