WAVELIGHT OCULYZER II DIAGNOSTIC DEVICE

Additional Manufacturer Narrative

CORRECTION INFORMATION PROVIDED IN D.4. UNIQUE DEVICE IDENTIFICATION (UDI) NUMBER ADDED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

Additional Manufacturer Narrative

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. A REVIEW OF THE TECHNICAL SERVICE ONSITE HISTORY SHOWED NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THIS EVENT. LASER WAS SUCCESSFULLY VERIFIED PRIOR AND AFTER THE DAY OF EVENT. MOST RECENT ONSITE VISIT FROM FIELD SERVICE ENGINEER WAS ON FIELD SERVICE ENGINEER PERFORMED AND SIGNED SERVICE INSTALLATION RECORD. SYSTEM MEETS SPECIFICATION AS PER SERVICE INSTALLATION RECORD. DURING ONSITE VISIT THE FIELD SERVICE ENGINEER PERFORMED SYSTEM VERIFICATION. ALL READINGS WERE WITHIN SPECIFICATION. FIELD SERVICE ENGINEER PERFORMED SYSTEM VERIFICATION AS PER SERVICE INSTALLATION RECORD. THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED CONCLUSIVELY, AS NO PROBLEM OR MALFUNCTION COULD BE DETECTED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

Description of Event or Problem

A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE MEASUREMENTS PROVIDED BY SYSTEM WERE A BIT OFF DURING UNKNOWN TIMING OF THE SURGERY.

Additional Manufacturer Narrative

H.6.: 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).