VERION DIGITAL MARKER M

Additional Manufacturer Narrative

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. (B)(4).

Description of Event or Problem

A DOCTOR REPORTED TORIC AXIS TAB SWITCHED OVER TO LEFT EYE WHEN PERFORMING A CATARACT PROCEDURE ON A PATIENT'S RIGHT EYE. INCISION AND CAPSULORHEXIS TAB WERE USED FOR RIGHT EYE SUCCESSFULLY PRIOR. THE SURGEON DID NOT NOTICE THE INCORRECT AXIS AT FIRST. IT WAS NOT UNTIL THE NURSE WENT TO THE FINALIZATION SCREEN AND WAS CONFIRMING THE INFORMATION THAT LEFT EYE WAS NOTICED. INTRAOCULAR POWER WAS ALSO INCORRECT FOR THE RIGHT EYE SINCE IT WAS SHOWING THAT THE LEFT EYE WAS BEING PERFORMED. THE DOCTOR WENT BACK TO THE AXIS SCREEN AND DOUBLE CHECKED AND IT WAS INCORRECT. THE SURGEON THEN ROTATED THE INTRAOCULAR LENS INTO THE CORRECT POSITION PER HIS MEDICAL CHART.

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORD WAS REVIEWED. NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THIS EVENT WERE FOUND AND THE PRODUCT WAS RELEASED ACCORDING TO COMPANY ACCEPTANCE CRITERIA. ON THE BASIS OF THE DATA RECEIVED, IT COULD COMPREHENDED AN OPERATOR ERROR. IT CANNOT EXACTLY BE DETERMINED HOW OR WHEN THE FAULT OCCURRED BUT DUE TO THIS INFORMATION, THE SYSTEM HAD LOADED THE DATA CORRECTLY. (B)(4).