BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WAVELIGHT EX500 EXCIMER LASER

    MDR report key: 11361989 · Received February 22, 2021

    Report

    Report Number
    3003288808-2021-00102
    Event Type
    Malfunction
    Date Received
    February 22, 2021
    Report Date
    February 22, 2021
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P020050
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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. DURING TECHNICAL SITE VISIT, FSE (FIELD SERVICE ENGINEER) CONFIRMED ISSUE, VERIFIED EYE TRACKER OPERATION ACCORDING TO SIR (SERVICE INSTALLATION RECORD) SPECIFICATIONS. FOUND LIGHTING SOURCES COVERED WITH BSS (BALANCED SALT SOLUTION), CLEANED AND PERFORMED VERIFICATION. SYSTEM PERFORMING WITHIN SPECIFICATIONS. THE ROOT CAUSE COULD BE DETERMINED CONCLUSIVELY AS USER HANDLING, EYE TRACKER LIGHT SOURCES WERE COVERED WITH BALANCED SALT SOLUTION. THE USER NEEDS TO MAKE SURE SOLUTIONS DO NOT GET ON THE EYE TRACKER AND OBSTRUCT IT'S FUNCTIONALITY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A FACILITY REPRESENTATIVE REPORTED THAT THEY HAD DIFFICULT TIME TRACKING LIGHT BLUE EYES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253813 WAVELIGHT EX500 EXCIMER LASER OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1