VERION DIGITAL MARKER M

Additional Manufacturer Narrative

A SERVICE VISIT WAS PERFORMED. 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NOT RECEIVED. (B)(4).

Description of Event or Problem

AN OPHTHALMIC SURGEON REPORTED THAT THE IMPLANTATION AXIS WAS NOTICED TO BE NOT CORRECT IN A POOL OF PATIENTS AFTER CATARACT SURGERIES WITH INTRAOCULAR LENS (IOL) IMPLANT. THIS REPORT IS FOR A PATIENT WHO HAD A 30ꠇAP IN THE IMPLANTATION AXIS. IT IS UNKNOWN IF ANY INTERVENTION WAS PERFORMED ON THIS PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED. THIS IS ONE OF THREE REPORTS BEING FILED FOR THE SAME FACILITY AND EVENT.

Additional Manufacturer Narrative

EVALUATION SUMMARY: SAMPLE WAS NOT RETURNED. NO MICROSCOPE DATA FOR THE RELATED PATIENT (PREOP/POSTOP/) RECEIVED. NO TECHNICAL ROOT CAUSE COULD BE DETERMINED BASED ON THE INFORMATION THAT WAS PROVIDED. CONTRIBUTING FACTORS FOR REPORTED EVENT COULD BE A SELECTING INCORRECT DOCTOR POSITION DURING PLANNING PHASE, A CHANGING OF DOCTOR/MICROSCOPE POSITION AFTER CONFIRMATION OF THE REGISTRATION OR GUIDELINES OF AN APPROPRIATE SURGERY IMAGE WHERE NOT FOLLOWED (E.G TOO LOW MICROSCOPE ILLUMINATION, ZOOM LEVEL OF THE MICROSCOPE TOO HIGH OR TOO LOW OR BAD CENTRATION OF THE EYE DURING THE SURGERY). MOST LIKELY THE ROOT CAUSE IS USE ERROR. (B)(4).