BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IRIDEX

    MDR report key: 1661542 · Received April 13, 2010

    Report

    Report Number
    MW5015543
    Event Type
    Injury
    Date Received
    April 13, 2010
    Date of Event
    March 25, 2010
    Report Date
    April 13, 2010
    Manufacturer
    IRIDEX CORPORATION
    Product Code
    HQF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NO PATIENT INJURY. THE DEVICE WAS USED PREINCISIONALLY. THE LASER FIBER HAS A BROKEN LIGHT AND WILL NOT REACH THE TIP FOR THE THERAPEUTIC USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IRIDEX LASER FIBER HQF IRIDEX CORPORATION 23G 01343

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability