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 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: THE DEVICE WAS SUCCESSFULLY VERIFIED PRIOR AND AFTER THE DAY OF EVENT. MOST RECENT ONSITE VISIT FROM FIELD SERVICE ENGINEER WAS PERFORMED AND SIGNED SERVICE INSTALLATION RECORD. THE DEVICE MEETS SPECIFICATION AS PER SERVICE INSTALLATION RECORD. THE REVIEW OF LOGFILE FOR THE DAY OF TREATMENT SHOWS ALL LASER SYSTEM FUNCTIONS WERE WITHIN SPECIFICATIONS. THE VACUUM CHECK, THE ENERGY CHECK AND THE ABLATION CHECK WERE PERFORMED SUCCESSFULLY WITHOUT ISSUES. THE ENERGY WAS STABLE DURING THE WHOLE DAY. THE REPORTED TREATMENT COULD BE IDENTIFIED IN THE LOGFILE. THE LOGFILE SHOWS THAT THE BEAM CONTROL CHECK WAS PERFORMED ABOUT TWO MINUTES AND FORTY-ONE SECONDS BEFORE THE START OF THE TREATMENT AND NOT IMMEDIATELY BEFORE THE TREATMENT. THE TREATMENT OF THE PATIENT'S LEFT EYE WAS FINISHED SUCCESSFULLY WITHOUT ANY ISSUE. NO RELEVANT DEVIATION BETWEEN PLANNED AND PERFORMED ENERGY IS DETECTABLE FOR THE REPORTED TREATMENT. THE USER OPERATED WITHIN THE RECOMMENDED ENERGY SETTINGS. REVIEW OF THE LOGFILES FOR THE TREATMENT DAY SHOWS NO RELEVANT WARNING OR ERROR MESSAGES. NO TECHNICAL ROOT CAUSE COULD BE IDENTIFIED. THE SYSTEM WAS WORKING WITHIN SPECIFICATION. NO COMPLAINT-RELATED PRODUCT IS EXPECTED TO RETURN FOR INVESTIGATION. NO DEVICE RELATED ISSUES WERE IDENTIFIED BASED ON THE PROVIDED DATA. THEREFORE, THE CASE IS CODED AS "INCONCLUSIVE - PRODUCT MET SPECIFICATIONS". THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

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 PATIENT EXPERIENCED DIFFUSE LAMELLAR KERATITIS IN THE LEFT EYE AFTER REFRACTIVE SURGERY. THE DIFFUSE LAMELLAR KERATITIS PATIENTS ARE DOING VISUALLY GOOD. FIELD SERVICE ENGINEER WENT TO THE SITE AND CHECKED THE LASER, AND IT IS WORKING CORRECTLY. THE SITE HAS AN AIR PURIFIER IN THE ROOM BUT STATED THEY HAVE NOT CHANGED THE FILTER IN A VERY LONG TIME, COULD BE A YEAR. THEY WERE REVIEWED WITH THE SITE THEY COULD CHECK THE AIR QUALITY IN THE ROOM AS WELL. THEY STATED NOTHING HAS CHANGED IN THEIR STERILIZATION PROCESS. THEY ARE CONTINUING TO FOLLOW UP WITH PATIENTS. THERE ARE MULTIPLE RELATED REPORTS FOR THIS EVENT. THIS REPORT ADDRESSES THE PATIENT (B)(6), LEFT EYE AND OTHER MANUFACTURER REPORTS WILL BE FILED.