BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WAVELIGHT FS200 FEMTOSECOND LASER

    MDR report key: 23645422 · Received November 25, 2025

    Report

    Report Number
    3003288808-2025-00540
    Event Type
    Malfunction
    Date Received
    November 25, 2025
    Report Date
    February 23, 2026
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    GEX
    PMA / PMN Number
    K101006
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN H.3., H.6., AND H.11. HOWEVER, ALL PRODUCT AND BATCH HISTORY RECORDS ARE QUALITY REVIEWED PRIOR TO PRODUCT RELEASE, ENSURING THAT ALL PRODUCTS ON THE MARKET FULFILL THE RELEVANT REQUIREMENTS. NO SERIAL NUMBER WAS IDENTIFIED WITHIN THE ARTICLE AND THEREFORE WITHIN THIS COMPLAINT, WHICH IS WHY THE ASSOCIATED MANUFACTURING DOCUMENTATION COULD NOT BE REVIEWED. SINCE THE COMPLAINT WAS OPENED BASED ON AN ARTICLE IN SCIENTIFIC LITERATURE, NO SAMPLE IS AVAILABLE TO BE PROVIDED TO THE RESPONSIBLE SITE FOR AN IN-DEPTH INVESTIGATION. DUE TO THE NATURE OF THE ARTICLE PUBLISHED IN SCIENTIFIC LITERATURE, INFORMATION REQUIRED TO PERFORM A PROPER COMPLAINT INVESTIGATION IS NOT MADE AVAILABLE. THEREFORE, THE ROOT CAUSE OF THE EVENTS INCLUDED IN THE ARTICLE CANNOT BE IDENTIFIED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    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). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

    Description of Event or Problem · 0

    A LITERATURE ARTICLE STUDY REPORTED THAT THE FLAP REPOSITIONING CORNEAL FLAP IRREGULAR) IN THE UNKNOWN EYE OF A PATIENT HAD LED TO SATISFACTORY VISUAL OUTCOMES IN CASES OF ACUTE NON-TRAUMATIC FLAP DISLOCATION DURING REFRACTIVE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277984 WAVELIGHT FS200 FEMTOSECOND LASER POWERED LASER SURGICAL INSTRUMENT GEX WAVELIGHT GMBH NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown WAVELIGHT EX500 EXCIMER LASER