VERION DIGITAL MARKER M

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 THE SYSTEM WITH THE AXIS DISPLAY WAS INCONSISTENT WHERE THE GUIDANCE AXIS WAS DISPLAYED IN A RIGHT EYE OF A PATIENT AT DIFFERENT POSITION THAN INITIALLY SHOWN WHICH WAS OFF ABOUT THIRTY DEGREE . SO THE GUIDANCE DISPLAY WAS UNRELIABLE DURING SURGERY. THE SURGERY WAS COMPLETED. THE PATIENT IDENTIFIER IS NOT AVAILABLE. THERE'S NO PATIENT HARM.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION PROVIDED IN D.9., H.3., H.6., AND H.11. A REVIEW OF THE DEVICE HISTORY RECORD TRACEABLE TO THE REPORTED SERIAL NUMBER INDICATES THAT THE PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE PRODUCT¿S ACCEPTANCE CRITERIA. AN INVESTIGATION OF THE PROVIDED DATA BY THE PRODUCT MANUFACTURER'S SUBJECT MATTER EXPERT SHOWED THAT AXIS JUMPS WERE NOTICED DURING SURGERY. AT THE BEGINNING OF THE PROCEDURE, A RELIABLE REGISTRATION COULD BE PERFORMED, AND THE AXIS WAS INITIALLY DISPLAYED AT THE CORRECT ALIGNMENT. UPON COMPLETION OF A RETINAL PROCEDURE, THE LENS POSITION WAS BEING CHECKED, WHEN AN AXIS JUMP WAS NOTICED ON THE SYSTEM AND THE AXIS WAS DISPLAYED AT A DIFFERENT ALIGNMENT. AT THIS TIME, THE SYSTEM INDICATED BY THE TRACKING RANGE INDICATOR THAT TRACKING WAS OUT OF RANGE AT THIS INSTANCE. FOR A RELIABLE TRACKING PERFORMANCE, STATUS MESSAGES INDICATING THE BEST COURSE OF ACTION ARE PROVIDED ON THE SCREEN. ONCE THE EYE WAS RECENTERED AND THE TRACKING RESUMED, THE ORIGINAL POSITION OF THE ALIGNMENT AXIS WAS DISPLAYED AGAIN. A CORRESPONDING STATUS MESSAGE WAS DISPLAYED ON THE SCREEN AND THE TRACKING RANGE INDICATOR SHOWED, NO ISSUES WITH THE DEVICE COULD BE IDENTIFIED AND THE CORRECT AXIS ALIGNMENT WAS RESUMED ONCE THE EYE WAS POSITIONED WITHIN THE TRACKING RANGE. AS THE DISPLAYED DATA WAS NOT INTERPRETED CORRECTLY BY THE CUSTOMER. THIS CASE IS CODED AS "EXTERNAL - OTHER". THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).