BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVELIGHT EX500 EXCIMER LASER

    MDR report key: 23504768 · Received November 8, 2025

    Report

    Report Number
    3003288808-2025-00503
    Event Type
    Injury
    Date Received
    November 8, 2025
    Date of Event
    September 30, 2024
    Report Date
    February 5, 2026
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P020050
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 D.9., 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. A REVIEW OF THE TECHNICAL SERVICE ONSITE HISTORY SHOWED NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THIS EVENT. WITHIN THE PREVENTIVE MAINTENANCE PROGRAM, THE DEVICE WAS REGULARLY SERVICED AND WAS SUCCESSFULLY VERIFIED PRIOR TO AND AFTER THE SURGERY DATE. MOST RECENT TECHNICAL SITE VISIT AND CONFIRMED DEVICE MET SPECIFICATIONS AS PER SERVICE AND INSTALLATION RECORD. LOGFILE REVIEW FOR THE DAY OF TREATMENT SHOWS THAT ALL LASER SYSTEM FUNCTIONS WERE WITHIN SPECIFICATIONS FOR THE RESPECTIVE TREATMENT. THE LOGFILE SHOWS THIRTY-EIGHT SUCCESSFULLY PERFORMED TREATMENTS ON THAT DAY. THE LOGFILE SHOWS THAT THE REPORTED TREATMENT RIGHT EYE WAS PERFORMED SUCCESSFULLY. THE INTERRUPTIONS WERE CAUSED BY THE USER RELEASING THE LASER PEDAL. IT IS NOT APPARENT IN THE LOGFILES WHY THE USER RELEASED THE LASER PEDAL. 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 ASSESSMENT OF THE INFORMATION GATHERED DURING A SITE VISIT BY THE LOCAL CLINICAL APPLICATION SPECIALIST SHOWED THAT THE ISSUES REPORTED AS PART OF THIS COMPLAINT CLUSTER WERE NOT DIRECTLY RELATED TO THE DEVICE. INSTEAD, THE FACTORS LISTED UNDER CLINICAL INFORMATION REVIEW WERE IDENTIFIED AS CONTRIBUTORS. THEREFORE, THE CASE IS CODED AS "INCONCLUSIVE - DEVICE MET SPECIFICATIONS". THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED THAT OVERCORRECTION IN THE RIGHT EYE OF A PATIENT AND THE POST OPERATIVE REFRACTIVE OUTCOME IS GREATER THAN IN MANIFEST REFRACTION SPHERICAL EQUIVALENT AFTER REFRACTIVE SURGERY. THERE ARE MULTIPLE RELATED REPORTS FOR THIS EVENT. THIS REPORT ADDRESSES THE PATIENT GGG, RIGHT EYE AND OTHER MANUFACTURER REPORTS WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1924263 WAVELIGHT EX500 EXCIMER LASER OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Male Other