VERION DIGITAL MARKER M

Additional Manufacturer Narrative

AN INCORRECT METHOD CODE WAS REPORTED ON MANUFACTURER REPORT NUMBER (B)(4) AND THE CORRECT CODE IS BEING REPORTED ON THIS MANUFACTURER REPORT. 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. ROOT CAUSE IS USER ERROR. INCORRECT MICROSCOPE ORIENTATION WAS SELECTED FOR THE FIRST SURGERY. DEVICE BEHAVED AS INTENDED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

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

Description of Event or Problem

A PHYSICIAN REPORTED A DEVIATION IN AXIS WAS DISPLAYED ON DIGITAL MARKER MICROSCOPE (DMM) DURING SURGERY. THE DOCTOR HAD DOUBTS ABOUT INSERTING THE INTRAOCULAR LENS (IOL) AT THE AXIS DISPLAYED ON DMM. AXIS DEVIATION OF ABOUT 20 DEGREES WAS FOUND POST SURGERY WHEN IOL POSITION WAS CHECKED. AN OPERATION TO ADJUST THE AXIS WAS LATER PERFORMED. THE SURGERY WAS COMPLETED. THE DOCTOR SAID THERE MIGHT HAVE BEEN A DIFFERENCE BETWEEN THE POSITION OF A MICROSCOPE DURING SETUP AND ITS ACTUAL POSITION.