BEUDAMED
    FDA Enforcement Class II Terminated

    Femto LDV Z-Generation Femtosecond Surgical Lasers are used to perform ophthalmic surgeries.

    Recall: Z-0988-2015 · Reported January 21, 2015

    Enforcement

    Recall Number
    Z-0988-2015
    Event ID
    70024
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ziemer Usa Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 21, 2015
    Initiation Date
    December 18, 2014
    Classification Date
    January 15, 2015
    Termination Date
    February 20, 2018
    Address
    620 East Third Street, Alton, IL, 62002, United States

    Description

    Femto LDV Z-Generation Femtosecond Surgical Lasers are used to perform ophthalmic surgeries.

    Reason

    The devices were not shipped with the Starter Kits.

    Code Info

    Serial Numbers: FLM4184, FLM2003, FLM3324, FLM1409, FLM2906, FLM2136, FLM4948, FLM3134, FLM4587, FLM3281, FLM2179, FLM1467, FLM1239, FLM3361, FLM3319, FLM3685, FLM2915, FLM1230, FLM3229, FLM4094, FLM4135, FLM4545, FLM4905, FLM3913, FLM1680, FLM1776

    Distribution

    US: Nationwide (AL, CA, FL, GA, IL, MN, MO, NC, ND, NH, NJ, NM, NY, PA, TX, VA, WA)

    Quantity

    26 lasers