VERION DIGITAL MARKER M

Additional Manufacturer Narrative

ADDITIONAL INFORMATION PROVIDED. AN ANALYSIS OF THE PROCEDURE FILES WAS PERFORMED. A DOCTOR POSITION OF 67.5° WAS SELECTED ON THE PLANNING SCREEN AND AN IMPLANTATION AXIS OF 96°. PROPOSED REGISTRATION ANGLE OF 2° WAS CONFIRMED BY USER WITHOUT MANUAL ADJUSTMENT. THE DOCTOR POSITION WAS SET TO 67.5 DEGREE AND PRIOR TO STARTING SURGERY THE PROPOSED 2° OF CONFIRMED REGISTRATION WAS REVIEWED. THE SETTINGS WERE REVIEWED AND CONFIRMED AT REGISTRATION. REVIEWING THE TRACKING OVERLAY FOR TORIC ALIGNMENT THROUGHOUT THE SURGERY, THE DISPLAYED IMPLANTATION AXIS MATCHED ONE OF THE MANUAL MARKS CREATED BY THE SURGEON. IT WAS VERIFIED IN THE LAST FRAMES OF THE SURGERY THAT THE LENS WAS ALIGNED, THE TORIC MARKS OF THE LENS MATCH THE TORIC OVERLAY DISPLAYED BY THE SYSTEM. THE REPORTED BEHAVIOR CANNOT BE REPRODUCED. BASED ON THE AVAILABLE CLINICAL DATA, THE OVERLAY IS SHOWN ON THE PROPER POSITION. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

Additional Manufacturer Narrative

THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

Description of Event or Problem

ADDITIONAL INFORMATION RECEIVED; THE SURGEON MARKED 270 DEGREES ONLY. BASED ON THAT MARK HE SAID THE AXIS MARK ON THE SYSTEM WAS AT LEAST 15 DEGREES OFF. IMPLANTATION AXIS WAS SUPPOSED TO BE AT 97 AND HE COULD NOT SEE THE PEN MARK FROM THE SCREEN. THE IMPLANTATION AXIS WAS ADJUSTED BY THE SURGEON AND THE DEVICE SUGGESTED AXIS WAS NOT USED.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION HAS BEEN REQUESTED. THE DEVICE HISTORY RECORD FOR THE AFFECTED LOT WAS REVIEWED. NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THIS EVENT WERE FOUND IN THE PRODUCTION DOCUMENTATION. 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 SURGEON REPORTED, THE INSTALLATION AXIS ON THE MICROSCOPE DISPLAY SHOWED THE WRONG AXIS COMPARED TO HIS OWN MARKING PRIOR TO IMAGE GUIDED CATARACT SURGERY.. THE DIFFERENCE IN THE AXIS WAS AT LEAST 15 DEGREES. THEY DID A RE-REGISTRATION OF THE EYE BUT IT DID NOT RESOLVE THE ISSUE. THE SURGERY WAS COMPLETED WITH A DIFFERENT PRODUCTS WITHOUT FURTHER ISSUES OR PATIENT HARM.