BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVELIGHT FS200 FEMTOSECOND LASER

    MDR report key: 23434376 · Received October 31, 2025

    Report

    Report Number
    3003288808-2025-00492
    Event Type
    Injury
    Date Received
    October 31, 2025
    Report Date
    March 10, 2026
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    GEX
    PMA / PMN Number
    K101006
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    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).

    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. 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 COULD NOT BE IDENTIFIED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A LITERATURE STUDY WAS INCLUDED 80 PARTICIPANTS, OF WHOM SEVEN THREE PATIENTS COMPLETED ALL FOLLOW-UP ASSESSMENTS THE SYSTEM WAS USED TO CREATE A CORNEAL FLAP IT LED TO SIGNIFICANT CORNEAL NERVE DAMAGE AND REDUCED SENSITIVITY AND INCOMPLETE RECOVERY EVEN AFTER ONE YEAR AFTER REFRACTIVE SURGERY. CITATION: FROM THE DEPARTMENT OF OPHTHALMOLOGY, PEKING UNIVERSITY THIRD HOSPITAL, BEIJING KEY LABORATORY OF RESTORATION OF DAMAGED OCULAR NERVE, PEKING UNIVERSITY THIRD HOSPITAL, BEIJING, CHINA (LZ, YZHANG, HYD, BKM, YZHOU, YGC, HQ); THE DEPARTMENT OF OPHTHALMOLOGY, GUANGDONG PROVINCIAL PEOPLE¿S HOSPITAL (GUANGDONG ACADEMY OF MEDICAL SCIENCES), SOUTHERN MEDICAL UNIVERSITY, GUANGZHOU, CHINA (TY); AND INSTITUTE OF MEDICAL TECHNOLOGY, PEKING UNIVERSITY HEALTH SCIENCE CENTER, BEIJING, CHINA (JWC, HQ).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84315 WAVELIGHT FS200 FEMTOSECOND LASER POWERED LASER SURGICAL INSTRUMENT GEX WAVELIGHT GMBH NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other