VERION DIGITAL MARKER M

Additional Manufacturer Narrative

CORRECTED INFORMATION PROVIDED IN H.11. ADDITIONAL INFORMATION PROVIDED IN D.4. AND H.4. UPON FURTHER REVIEW THIS COMPLAINT WAS REASSESSED AND CONFIRMED THAT, THIS EVENT DOES NOT MEET CRITERIA FOR REPORTING AS A REPORTABLE MALFUNCTION AS THERE WAS NO PATIENT HARM WITH THE PRODUCT AND THE ISSUE WAS NOTED WITH THE CABLE DURING SURGERY. NO FURTHER REGULATORY REPORTS REQUIRED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

Additional Manufacturer Narrative

H.3., H.6.: 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 HEALTHCARE PROFESSIONAL REPORTED THAT A MICROSCOPE-INTEGRATED DISPLAY FAILURE OCCURRED, CAUSING THE DISPLAY GUIDE TO TURN ON AND OFF DURING AN UNSPECIFIED SURGERY ON THE PATIENT'S EYE. THE PROCEDURE WAS COMPLETED WITH MANUAL MARKING. THERE WAS NO PATIENT HARM REPORTED.