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, FIELD SERVICE ENGINEER PERFORMED AND SIGNED SERVICE INSTALLATION RECORD. THE DEVICE MEETS SPECIFICATION AS PER SERVICE INSTALLATION RECORD. TYPICALLY, DIFFUSE LAMELLAR KERATITIS IS NOT DIRECTLY ATTRIBUTABLE TO THE DEVICE. CONTRIBUTING FACTORS OF DIFFUSE LAMELLAR KERATITIS COULD BE STERILIZATION OF INSTRUMENTS, ENVIRONMENT OF THE FACILITY, SURGICAL TECHNIQUES AS WELL AS PRE AND POST-OPERATIVE MEDICATIONS. THE REVIEW OF LOGFILE FOR THE DAY OF TREATMENT SHOWS ALL LASER SYSTEM FUNCTIONS WERE WITHIN SPECIFICATIONS. THE ENERGY WAS STABLE DURING THE WHOLE DAY. THE REPORTED TREATMENT COULD BE IDENTIFIED IN THE LOGFILE. AFTER THE USER SUCCESSFULLY ESTABLISHED PROPER VACUUM ONE AND TWO THE USER SWITCHED OF THE VACUUM AND REMOVED AND REINSERTED THE CONE THREE ADDITIONAL TIMES. AFTERWARDS THE USER STARTED THE DOCKING PROCESS AGAIN REACHED A VALID SUCTION ONE AND TWO VALUE. SUCTION RING AND PATIENT INTERFACE WERE DOCKED TWICE ON PATIENT¿S EYE. 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 PHYSICIAN REPORTED THAT PATIENT HAD EXPERIENCED DIFFUSE LAMELLAR KERATITIS IN THE LEFT EYE AFTER REFRACTIVE SURGERY. THE DIFFUSE LAMELLAR KERATITIS WAS CAUSED DUE TO TOO MUCH CLEANING CHEMICALS PREVIOUSLY AND THE ROOM IS NOT WELL VENTILATED; PATIENTS ARE DOING VISUALLY GOOD. THE SITE ORDERED A NEW STERILIZER AS WELL AS NEW INSTRUMENTS. FILED SERVICE ENGINEER WENT TO THE SITE AND CHECKED THE SYSTEM 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; THEY STATED NOTHING HAS CHANGED IN THEIR STERILIZATION PROCESS. THEY ARE CONTINUING TO FOLLOW UP WITH PATIENTS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT. THERE ARE MULTIPLE RELATED REPORTS FOR THIS FACILITY. THIS REPORT ADDRESSES THE PATIENT (B)(6), LEFT EYE AND OTHER MANUFACTURER REPORTS WILL BE FILED.