BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVELIGHT FS200 FEMTOSECOND LASER

    MDR report key: 19313245 · Received May 14, 2024

    Report

    Report Number
    3003288808-2024-00124
    Event Type
    Injury
    Date Received
    May 14, 2024
    Date of Event
    April 18, 2024
    Report Date
    October 1, 2024
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    OOE
    PMA / PMN Number
    K141476
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN 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. THE REVIEW OF LOGFILE FOR THE TREATMENT DAY SHOWS ALL LASER SYSTEM FUNCTIONS WERE WITHIN SPECIFICATIONS. THE INITIALIZATION CHECKS WERE PERFORMED SUCCESSFULLY WITHOUT ISSUES. THE ENERGY WAS STABLE DURING THE WHOLE DAY. THE LOGFILE SHOWS TWENTY-SIX SUCCESSFULLY PERFORMED TREATMENTS WITHOUT INTERRUPTIONS. DUE TO MISSING INFORMATION ABOUT THE TREATMENT DETAILS THE RELATED TREATMENT CANNOT BE IDENTIFIED IN THE LOGFILE. THE REVIEW OF THE COMPLETE TREATMENT DAY SHOWS THAT FIFTEEN BEAM CONTROL CHECKS WERE PERFORMED WAY BEFORE THE START OF THE TREATMENTS AND NOT IMMEDIATELY BEFORE THE TREATMENTS. THE REVIEW ALSO SHOWS THAT DURING TWENTY TREATMENTS THE SUCTION PROCESS WAS ACHIEVED WITHOUT MISSED VACUUM ONE OR TWO AND RE-DOCKINGS. DURING SIX TREATMENTS THE SURGEON HAS HAD DIFFICULTIES TO REACH A VALID SUCTION ONE AND TWO VALUE RESULTING IN MULTIPLE DOCKING ATTEMPTS. ADDITIONALLY, THE USER CANCELLED TWO TREATMENTS BEFORE LASER APPLICATION AND THE DEVICE ABORTED ONE TREATMENT DURING THE BEAM CONTROL CHECK. THE REVIEW ALSO SHOWS THAT ALL TREATMENTS WERE PERFORMED WITH NO OR NOT RELEVANT DEVIATION BETWEEN PLANED AND PERFORMED ENERGY. 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. ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE AVAILABLE INFORMATION. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A CUSTOMER REPORTED A FLAP COMPLICATION INVOLVING DAMAGE AND TEARING, AS WELL AS INCOMPLETE FLAP OCCURRENCE DURING SUCTION DISPLACEMENT ON THE PATIENT'S RIGHT EYE, DURING LASIK SURGERY. TO ADDRESS THIS, SCISSORS WERE MANUALLY USED TO COMPLETE AND LIFT THE FLAP. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, THE PATIENT HAS REPORTED FEELING STITCHES IN HER EYE. THERE ARE MULTIPLE RELATED REPORTS FOR THIS REPORTED EVENT. THIS REPORT ADDRESSES PATIENT INITIALS NN, RIGHT EYE, AND ADDITIONAL MANUFACTURER REPORTS WILL BE FILED FOR THE OTHER PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635203 WAVELIGHT FS200 FEMTOSECOND LASER OPHTHALMIC LASER OOE WAVELIGHT GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Female Required Intervention WAVELIGHT EX500 EXCIMER LASER