VERION DIGITAL MARKER M

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. THE MANUFACTURER'S SUBJECT MATTER EXPERT INVESTIGATED THE PROVIDED DATA AND FOUND THAT THE SURGEON MISINTERPRETED THE ORTHOGONAL AXIS INTENDED TO PROVIDE FEEDBACK ON THE DETECTED LIMBUS IN THE FRAME TO BE THE IMPLANTATION AXIS. WHEN THE IMPLANTATION AXIS IS IN FACT NINETY DEGREES ORTHOGONAL TO IT AND CLEARLY INDICATED WITH THE IMPLANTATION AXIS VALUE BESIDES IT. THIS MISINTERPRETATION OF THE AXES, LEAD TO THE MISALIGNMENT OF THE LENS BY NINETY DEGREES. THE REPORTED ISSUE WAS CAUSED BY MISINTERPRETATION OF THE IMPLANTATION AXIS. THEREFORE, THE ROOT CAUSE CODE IS SELECTED AS "EXTERNAL - USER HANDLING". 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 THE LENS WAS ORIENTED TO NINETY DEGREES AWAY FROM THE PLANNED AXIS IN THE RIGHT EYE OF A PATIENT DURING CATARACT SURGERY. THE VISION OF THE PATIENT WAS SUBOPTIMAL. THERE IS NO UNPLANNED MEDICAL OR SURGICAL INTERVENTION AT TIME OF EVENT. LENS ROTATED TO CORRECT ORIENTATION.