FINESSE FLEX LOOP DSP

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 HEALTH CARE PROFESSIONAL REPORTED THAT PORTION OF THE LOOP WAS BROKEN AND LEFT INSIDE THE EYE BUT WAS LATER REMOVED. PATIENT AND PROCEDURE DETAILS WERE NOT REPORTED. PATIENT IMPACT WAS NOT REPORTED.