WAVELIGHT FS200 FEMTOSECOND LASER

Additional Manufacturer Narrative

ADDITIONAL INFORMATION PROVIDED IN D.9., H.3., H.6., AND H.11. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) 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 REVIEW SHOWED NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THIS EVENT. THE DEVICE WAS SUCCESSFULLY VERIFIED PRIOR AND AFTER THE DAY OF EVENT. MOST RECENT ONSITE VISIT FROM FIELD SERVICE ENGINEER PERFORMED AND SIGNED SERVICE INSTALLATION RECORD (SIR). SYSTEM MEETS SPECIFICATION AS PER SERVICE INSTALLATION RECORD. DURING ONSITE VISIT THE FIELD SERVICE ENGINEER REPLACED THE F-THETA. FIELD SERVICE ENGINEER PERFORMED SYSTEM VERIFICATION AS PER SERVICE INSTALLATION RECORD. THE REVIEW OF LOGFILE CONFIRMS THE REPORTED SCANNER ISSUE. THE ERROR MESSAGE (SCANNER INTERLOCK ACTIVATED) APPEARED EIGHT TIMES DURING THIS PERIOD. THE ERROR MESSAGE (SCANNER COULD NOT BE INITIALIZED) APPEARED THREE TIMES DURING THIS PERIOD. NONE OF THE MENTIONED ERRORS OCCURRED DURING TREATMENT. REVIEW OF THE LOGFILES FOR THE PERIOD DOES NOT SHOW ANY OTHER RELEVANT WARNING OR ERROR MESSAGES. THE LOGFILE SHOWS ONE ZERO SIX SUCCESSFULLY PERFORMED TREATMENTS IN THIS PERIOD. THE ROOT CAUSE COULD NOT BE IDENTIFIED DURING LOGFILE REVIEW. THE REPLACED PART WAS RECEIVED AT MANUFACTURER AND FORWARDED FOR INVESTIGATION TO THE RESPONSIBLE SUPPLIER. THE ROOT CAUSE OF THE REPORTED CLINICAL EVENT COULD NOT BE DETERMINED. NOT ENOUGH INFORMATION WAS PROVIDED TO PROPERLY COMPLETE AN INVESTIGATION. THE ROOT CAUSE OF THE REPORTED TECHNICAL EVENT COULD NOT BE DETERMINED CONCLUSIVELY. MOST POSSIBLE ROOT CAUSE IS A FAULTY SCANNER. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

Description of Event or Problem

A NON-HEALTHCARE PROFESSIONAL REPORTED DIFFICULTY IN LIFTING THE FLAP OF THE PATIENT'S UNKNOWN EYE DURING REFRACTIVE SURGERY. THE SURGERY WAS COMPLETED WITH NO PATIENT HARM. DURING THE SITE INSPECTION, ENGINEER FOUND DEBRIS INSIDE THE MIRROR AND STAINS ON THE SURFACE OF THE LENS, ADDITIONALLY THERE WAS A PROBLEM OBSERVED WITH THE FILTER OF THE REFERENCE CAMERA WITH CRACKS IN IT. THEIR SCANNER WAS FOUND TO BE FAULTY AS WELL.

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).