BEUDAMED
    FDA Enforcement Class II Terminated

    Endophotocoagulation Delivery 4EP-1 of GYC-1000 Green Laser Photocoagulator System; GYC4EP-01 0W02 and GYC4EP-1 0Z20; The Nidek Green Laser Photocoagulator Model GYC- 1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.

    Recall: Z-2068-2015 · Reported July 22, 2015

    Enforcement

    Recall Number
    Z-2068-2015
    Event ID
    71527
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Nidek Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 22, 2015
    Initiation Date
    March 25, 2015
    Classification Date
    July 14, 2015
    Termination Date
    July 14, 2015
    Address
    47651 Westinghouse Dr, N/A, Fremont, CA, 94539-7474, United States

    Description

    Endophotocoagulation Delivery 4EP-1 of GYC-1000 Green Laser Photocoagulator System; GYC4EP-01 0W02 and GYC4EP-1 0Z20; The Nidek Green Laser Photocoagulator Model GYC- 1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.

    Reason

    Accessories to the GYC-1000 laser were missing Laser Aperture labels.

    Code Info

    Model GYC4EP-01 0W02 and GYC4EP-1 0Z20;

    Distribution

    US Distribution to the states of : CA, IL, MN, MO, OR, IL, UT RI, MA, WA, NE, NY, NJ, TX and WI.

    Quantity

    W020 - 1 unit; 0Z20- 6 units