VERION DIGITAL MARKER M

Additional Manufacturer Narrative

ADDITIONAL INFORMATION PROVIDED: ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, CUSTOMER IS UNWILLING TO PROVIDE ANY ADDITIONAL INFORMATION RELATED TO THIS EVENT. NO TECHNICAL ROOT CAUSE COULD BE DETERMINED AS THE SYSTEM WAS PERFORMING WITHIN SPECIFICATIONS. CONTRIBUTING FACTORS COULD BE MISUSE OF THE DEVICE, THE SURGEON HAS TO REVIEW AND CONFIRM SURGICAL PLANNING SCREEN BEFORE THE TREATMENT. AS PER INVESTIGATION, OBSERVED ERROR IN AXIS MAPPING DUE TO WRONG DOCTOR POSITION. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

Description of Event or Problem

ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, CUSTOMER IS UNWILLING TO PROVIDE ANY ADDITIONAL INFORMATION RELATED TO THIS EVENT.

Description of Event or Problem

SURGEON REPORTED TO COMPANY REPRESENTATIVE A CASE OF INCORRECT PLACEMENT OF INCISIONS RESULTED IN INCORRECT ORIENTATION OF A TORIC INTRAOCULAR LENS (IOL) IN A PATIENT'S LEFT EYE. REPORTER INDICATED A RESIDUAL POSTOPERATIVE ASTIGMATISM OCCURED, AND THE PATIENT WAS RETURNED TO THE OPERATING ROOM ON THE SAME DAY WHERE THE IOL WAS ROTATED TO THE CORRECT AXIAL POSITION. REPORTER INDICATED THE PATIENT IS DOING WELL. FOLLOW UP INFORMATION RELAYED USER HAD MISSED THE SELECTION OF PHYSICIAN ORIENTATION OF THE DEVICE TO DETERMINE CORRECT REGISTER OF INCISIONS.

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).