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 SURGEON NOTICED INTRAOCULAR LENS WAS MISALIGNED BY AROUND NINETY DEGREES IN THE UNKNOWN EYE OF A PATIENT, AFTER SURGERY. THE SURGEON SUGGESTED COULD BE DUE TO ROTATION OF THE INTRAOCULAR LENS OR THE USER ERROR DUE TO MISALIGNMENT OF THE INTRAOCULAR LENS DURING SURGERY.

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 REPORTED ISSUE COULD NOT BE CONFIRMED VIA A REVIEW BY A MANUFACTURER'S PRODUCT SUBJECT MATTER EXPERT DUE TO INSUFFICIENT INFORMATION. HOWEVER, THE SUBJECT MATTER EXPERT ALSO CONCLUDED THAT THE CUSTOMER SUSPECTS THAT HE MAY HAVE MISALIGNED THE LENS RESULTING IN CUSTOMER DISSATISFACTION WITH THE INTRAOCULAR LENS OVERLAY AND A REQUESTED TO REMOVE THE ORTHOGONAL AXIS, WHICH COULD MISLEAD SURGEONS TO ALIGN THE LENS NINETY DEGREE OFF AXIS ACCORDING TO THE CUSTOMER. BASED ON THE PROVIDED INFORMATION, THE REPORTED EVENT COULD NOT BE CONFIRMED. REGARDLESS, THE ISSUE RESULTED IN CUSTOMER DISSATISFACTION WITH REGARDS TO THE DISPLAY OF THE DOTTE PERPENDICULAR/ORTHOGONAL AXIS. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).