BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IRIDEX OCCULIGHT SLX, AND OTHER IRIDEX LASER

    MDR report key: 1802931 · Received August 11, 2010

    Report

    Report Number
    MW5017084
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Report Date
    August 11, 2010
    Manufacturer
    IRIDEX CORPORATION
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    COMPANY, WHICH IS A MANUFACTURER OF SURGICAL AND OTHER MEDICAL LASER SYSTEMS, REFUSES TO COMPLY WITH 21 CFR 1040.10(H)(2)(II), AND 21 CFR 820.170, IN THAT COMPANY REFUSES TO MAKE AVAILABLE TO SERVICING DEALERS, DISTRIBUTORS, AND/OR 'OTHERS' UPON REQUEST INSTRUCTIONS FOR ASSEMBLY, OPERATION, AND MAINTENANCE, A LISTING OF ALL CONTROLS, ADJUSTMENTS, SPECIAL TOOLS, AND PROCEDURES FOR OPERATION AND MAINTENANCE, AND ADEQUATE INSTRUCTIONS FOR SERVICE ADJUSTMENTS AND SERVICE PROCEDURES PURSUANT TO 21 CFR 1040.10(H)(2)(II), AND INSTALLATION INFO PURSUANT TO 21 CFR 820.170 FOR ANY OF ITS LASER PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IRIDEX OCCULIGHT SLX, AND OTHER IRIDEX LASER OCCULIGHT SLX, AND OTHER IRIDEX LASER SYSTEMS GEX IRIDEX CORPORATION SL/SLX
    2 IRIDEX OCCULIGHT GLX, AND OTHER IRIDEX LASER OCCULIGHT GLX, AND OTHER IRIDEX LASER SYSTEMS GEX IRIDEX CORPORATION SL/GLX

    Patients

    Seq Age Sex Outcome Treatment
    1