VERION DIGITAL MARKER M

Additional Manufacturer Narrative

EVALUATION SUMMARY:SAMPLE WAS NOT RETURNED. NO ANOMALIES FOUND BY REVIEW OF DEVICE HISTORY RECORD. PRODUCT MET ALL SPECIFICATIONS WHEN RELEASED. NO TECHNICAL ROOT CAUSE COULD BE DETERMINED AS THE SYSTEM IS PERFORMING WITHIN SPECIFICATIONS. REPORTED ISSUE COULD NOT BE REPRODUCED BY THE FSE ON SITE. AFTER PERFORMING DATA COLLECTION TO FREE UP MEMORY SPACE, THE ISSUE WAS NEVER RECOGNIZED.

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. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE. (B)(4).

Description of Event or Problem

A FACILITY EMPLOYEE REPORTED THAT A SYSTEM SHUT DOWN WHILE A SURGEON WAS IMPLANTING A TORIC INTRAOCULAR LENS (IOL). NO ACTION WAS PERFORMED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE. THIS IS ONE OF TWO REPORTS BEING FILED FOR THIS FACILITY. THIS REPORT IS FOR A POOL OF PATIENTS.