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 HEALTHCARE PROFESSIONAL REPORTED THAT ACTUAL FLAP WAS THINNER THAN THE PLANNED FLAP THICKNESS ALONG WITH GAS BREAKTHROUGH, BUBBLES OBSERVED AND PROCEDURE WAS SWITCHED TO PHOTOREFRACTIVE KERATECTOMY AS SURGEON WAS UNABLE TO LIFT THE FLAP IN RIGHT EYE OF THE PATIENT DURING SURGERY. THE PROCEDURE WAS COMPLETED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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 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 WAS PERFORMED AND SIGNED SERVICE INSTALLATION RECORD. THE DEVICE MEETS SPECIFICATION AS PER SERVICE INSTALLATION RECORD. NO ASSOCIATED SERVICE VISIT FOR THE REPORTED EVENT COULD BE IDENTIFIED. 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 REPORTED TREATMENT COULD BE IDENTIFIED IN THE LOGFILE. THE LOGFILE SHOWS THAT THE BEAM CONTROL CHECK WAS PERFORMED ABOUT NINETY FOUR SECONDS BEFORE THE START OF THE TREATMENT AND NOT IMMEDIATELY BEFORE THE TREATMENT. THE BEAM CONTROL CHECK RESULTED IN A CORRECTION OF MINUS TWENTY ONE MICRONS. BEFORE THE TREATMENT COULD BE STARTED THE SYSTEM SHOWED THE WARNING MESSAGE INDICATING, THAT THE PEDAL WAS PRESSED TOO EARLY BY THE USER, BEFORE THE LASER WAS READY. THE TREATMENT OF THE PATIENT'S RIGHT EYE WAS FINISHED SUCCESSFULLY WITHOUT ANY ISSUE. THE USER OPERATED NOT WITHIN THE RECOMMENDED CANAL SETTINGS. THE CANAL WIDTH WAS SET TO ONE POINT NINE MILLIMETERS. THE RECOMMENDED SETTING FOR THE CANAL WIDTH IS BETWEEN ONE POINT TWO AND ONE POINT EIGHT MILLIMETERS. THE THICKNESS OF THE FLAP WAS THINNER THAN THE RECOMMENDED FLAP THICKNESS . 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. THE ISSUE "DOCTOR HAD TO PRESS FOOT PEDAL A COUPLE OF TIME BEFORE IT FIRED" OCCURRED ONLY DURING THIS TREATMENT. ACCORDING TO THE REPORTER THE ISSUES WAS ALREADY INVESTIGATED PREVIOUSLY BUT NOTHING UNUSUAL COULD BE IDENTIFIED WITH THE LASER. PER INFORMATION BY A LOCAL SUBJECT MATTER EXPERT, THE MOST LIKELY CAUSE FOR THIS ISSUE IS, THAT THE PEDAL WAS NOT PRESSED FAR ENOUGH DOWN. NO COMPLAINT-RELATED PRODUCT WAS RECEIVED FOR INVESTIGATION. NO DEVICE RELATED ISSUES WERE IDENTIFIED BASED ON THE PROVIDED DATA. THE INVESTIGATION SHOWED PATIENT AND/OR HANDLING RELATED FACTORS, THAT MAY CONTRIBUTE TO AN OUTCOME SIMILAR TO THE REPORTED EVENT. THEREFORE, THE CASE IS CODED AS "INCONCLUSIVE - OTHER". THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).