BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVELIGHT EX500 EXCIMER LASER

    MDR report key: 23657491 · Received November 26, 2025

    Report

    Report Number
    3003288808-2025-00547
    Event Type
    Injury
    Date Received
    November 26, 2025
    Report Date
    January 26, 2026
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P020050
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 COULD NOT BE IDENTIFIED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    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).

    Description of Event or Problem · 0

    A LITERATURE STUDY ARTICLE REPORTED THAT PATIENT HAD EXPERIENCED GRADE ONE DIFFUSE LAMELLAR KERATITIS, AND IT WAS FOUND IN FOUR UNKNOWN EYES AND ALL RESOLVED BY THE SECOND POSTOPERATIVE DAY AFTER REFRACTIVE SURGERY. CITATION: LOW JR, LIM L, KOH JCW, CHUA DKP, ROSMAN M. SIMULTANEOUS ACCELERATED CORNEAL CROSSLINKING AND LASER IN SITU KERATOMILEUSIS FOR THE TREATMENT OF HIGH MYOPIA IN ASIAN EYES. OPEN OPHTHALMOL J. 2018;12(SUPPL-1, M3):143¿153. DOI:10.2174/1874364101812010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1946657 WAVELIGHT EX500 EXCIMER LASER OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other