BEUDAMED
    FDA Enforcement Class II Terminated

    Iridex TruFocus LIO Premiere" Laser Indirect Ophthalmoscope ( LIO ) The LIO is a headmounted indirect ophthalmoscope which is used with a handheld lens to view and perform laser treatments on a patient s retina. It allows binocular visualization of the peripheral retina and can be used to evaluate and treat patients.

    Recall: Z-1075-2018 · Reported March 28, 2018

    Enforcement

    Recall Number
    Z-1075-2018
    Event ID
    79386
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Iridex Corporation
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    March 28, 2018
    Initiation Date
    February 27, 2018
    Classification Date
    March 16, 2018
    Termination Date
    September 22, 2023
    Address
    1212 Terra Bella Ave, N/A, Mountain View, CA, 94043-1824, United States

    Description

    Iridex TruFocus LIO Premiere" Laser Indirect Ophthalmoscope ( LIO ) The LIO is a headmounted indirect ophthalmoscope which is used with a handheld lens to view and perform laser treatments on a patient s retina. It allows binocular visualization of the peripheral retina and can be used to evaluate and treat patients.

    Reason

    It was discovered that the laser energy was not going where intended to put it, resulting in focal cataracts and iris burns.

    Code Info

    Device Identity : 87300, 87301, 87302, 87303, 87304

    Distribution

    Worldwide Distribution - USA Distribution and to the countries of : China, Germany, Australia, Canada, Ireland, Lebanon, Japan, Israel and Qatar

    Quantity

    US - 58 OUS - 46