BEUDAMED
    FDA Enforcement Class II Terminated

    Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use in the treatment of ocular pathology.

    Recall: Z-2191-2013 · Reported September 18, 2013

    Enforcement

    Recall Number
    Z-2191-2013
    Event ID
    66133
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Lumenis, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 18, 2013
    Initiation Date
    August 19, 2013
    Classification Date
    September 11, 2013
    Termination Date
    December 19, 2013
    Address
    3959 W 1820 S, N/A, Salt Lake City, UT, 84104, United States

    Description

    Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use in the treatment of ocular pathology.

    Reason

    Lumenis has initiated a recall on certain models of Vision One System due to a potential for unintended laser exposure to the user.

    Code Info

    Model: GA-0025020

    Distribution

    Distributed in the states of NJ, PA, and IL.

    Quantity

    3 units