VERION DIGITAL MARKER M

Additional Manufacturer Narrative

EVALUATION SUMMARY: NO ANOMALIES FOUND BY REVIEW OF DEVICE HISTORY RECORD, PRODUCT MET ALL SPECIFICATIONS WHEN RELEASED. PRODUCT WAS NOT RETURNED FOR INVESTIGATION. REQUESTED DATA WERE NOT PROVIDED FOR INVESTIGATION. A JUMPING AXIS CAN HAVE SEVERAL CAUSES. IF THE DOCTOR SELECTS THE WRONG DOCTOR POSITION, THE DEVICE WILL NOT BE ABLE TO REGISTER THE CORRECT ANGLE. POOR ILLUMINATION CAN ALSO BE A REASON FOR NOT PROPERLY REGISTERING. THE ROOT CAUSE OF THE EVENT WAS ATTRIBUTED TO USER HANDLING. THE DEVICE WILL BE REMOVED FROM THE SITE BECAUSE OF DISSATISFACTION OF THE SURGEON.

Additional Manufacturer Narrative

EVALUATION SUMMARY: 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 THAT DURING SURGERY, THE AXIS OF THE INTRAOCULAR LENS (IOL) IMPLANTATION MOVED APPROXIMATELY TEN TO FIFTEEN DEGREES FROM THE PLANNED POSITION. THE CONDITION OF THE PATIENT IS UNKNOWN. ALTHOUGH IT WAS REQUESTED, THE SURGEON WAS UNABLE TO PROVIDE ADDITIONAL INFORMATION. NO FURTHER INFORMATION IS EXPECTED.