UNKNOWN ILUX SYSTEM DEVICE

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS PROVIDED IN SECTIONS H.6 AND H.11. SPECIFIC PRODUCT IDENTIFIERS (LOT NUMBER) WERE NOT PROVIDED AND COULD NOT BE DETERMINED AT THIS TIME. HOWEVER, ALL DEVICE HISTORY RECORDS ARE REVIEWED PRIOR TO PRODUCT RELEASE TO ENSURE THE PRODUCT WAS MANUFACTURED IN COMPLIANCE WITH THE DEVICE MASTER RECORD AND MEETS RELEASE CRITERIA. A REVIEW FOR COMPLAINTS REPORTED AGAINST THIS SERIAL NUMBER CANNOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. THE LOT IS UNKNOWN. THEREFORE, A SERVICE HISTORY REVIEW CANNOT BE PERFORMED. BASED ON THE INFORMATION AVAILABLE, THE CUSTOMER REPORTED EVENT CANNOT BE CONFIRMED. BASED ON THE INFORMATION OBTAINED, THE ROOT CAUSE OF THE REPORTED EVENT IS INCONCLUSIVE. MANUFACTURER WILL CONTINUE TO MONITOR DATA FOR EVIDENCE OF ADVERSE TRENDING AND TAKE FURTHER ACTION, AS APPROPRIATE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

Description of Event or Problem

A HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY, A PATIENT EXPERIENCED CORNEAL ABRASION. IT WAS FURTHER REPORTED THAT REQUIRED ADDITIONAL MEDICAL INTERVENTION TO TREAT THE CORNEAL ABRASION. THE PATIENT IMPACT HAVE NOT BEEN PROVIDED.

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).