WAVELIGHT FS200 FEMTOSECOND LASER

Additional Manufacturer Narrative

H.3., 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).

Description of Event or Problem

A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE VERTICAL GAS BREAKTHROUGH IN THE UNKNOWN EYE OF A PATIENT, DURING REFRACTIVE SURGERY.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION PROVIDED IN D.9., H.3., H.6., AND H.11. A REVIEW OF THE BATCH 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: SYSTEM WAS SUCCESSFULLY VERIFIED AFTER THE SURGERY DATE. MOST RECENT ONSITE VISIT FROM FIELD SERVICE ENGINEER PERFORMED AND SIGNED SERVICE INSTALLATION RECORD. THE DEVICE MEETS SPECIFICATIONS AS PER SERVICE INSTALLATION RECORD. A SERVICE VISIT WAS PERFORMED AS A RESULT OF THE REPORTED EVENT: THE CUSTOMER STARTED THE SYSTEM UP ONE HOUR PRIOR TO ARRIVAL OF THE FIELD SERVICE ENGINEER. ONCE ONSITE SYSTEM CALIBRATION WAS PERFORMED. AFTER THE CALIBRATION WAS COMPLETED, SIX CUTS ON POLYMETHYL METHACRYLATE WERE PERFORMED. ALL CUTS WERE REPEATABLE IN DEPTH AND MEETS SPECIFICATIONS. CUTS LOOKED CLEAN AND ALL WITHIN THREE MICRONS OF EACH OTHER. NO LOGFILES ARE AVAILABLE FOR REVIEW. THEREFORE, LOGFILE REVIEW COULD NOT BE PERFORMED. NO COMPLAINT-RELATED PRODUCT WAS RECEIVED FOR INVESTIGATION. THE ROOT CAUSE CANNOT BE IDENTIFIED CONCLUSIVELY, BASED ON PROVIDED INFORMATION. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).