VERION DIGITAL MARKER M

Description of Event or Problem

A PHYSICIAN REPORTED THAT THE SURGEON HAD DIFFICULTY REGISTRATION WITH THE PATIENT'S UNKNOWN EYE ON THE DIGITAL MICROSCOPE MARKER AFTER COMPLETION AND OVERLAYS WERE INACCURATE BASED ON PRE-OPERATIVE PLAN OF CATARACT SURGERY.

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).

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 REPORTED PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE REPORTED PRODUCT¿S ACCEPTANCE CRITERIA. IT WAS REPORTED BY A LOCAL CLINICAL APPLICATION SPECIALIST THAT THE SURGEON HAD DIFFICULTY REGISTERING HIS PATIENT ON THE SYSTEM, AND THEN AFTER COMPLETING REGISTRATION THE SYSTEM OVERLAYS WERE INACCURATE BASED ON HIS PRE-OP PLAN. THE PRODUCT MANUFACTURER'S SUBJECT MATTER EXPERT WAS IN CONTACT WITH THE CLINICAL APPLICATION SPECIALIST TO OBTAIN THE ADDITIONAL DATA REQUIRED FOR THE INVESTIGATION. HOWEVER, ONLY THE LOGFILES WERE PROVIDED WHICH ARE INSUFFICIENT TO ASSESS THE SPECIFICS OF THE REPORTED CASE. THEREFORE, THE REPORTED EVENT COULD NOT BE CONFIRMED NOR COULD A ROOT CAUSE FOR THE REPORTED EVENT BE DETERMINED. ACCORDINGLY, THE ROOT CAUSE CODE "INCONCLUSIVE - INSUFFICIENT DATA PRODUCT OR PRODUCT DATA" WAS SELECTED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).