BEUDAMED
    FDA Enforcement Class II Terminated

    EC-5000 Excimer Laser Corneal Surgery System (EC-5000, EC 5000 CXIII, EC-5000 Quest. Opthalmic: NIDEK EXCIMER LASER CORNEAL SURGERY SYSTEM, model EC-5000, is an ophthalmic laser system used for correction of corneal refraction and ablation of the corneal surface.

    Recall: Z-1710-2015 · Reported June 10, 2015

    Enforcement

    Recall Number
    Z-1710-2015
    Event ID
    71098
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Nidek Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 10, 2015
    Initiation Date
    March 24, 2015
    Classification Date
    June 4, 2015
    Termination Date
    April 5, 2016
    Address
    47651 Westinghouse Dr, N/A, Fremont, CA, 94539-7474, United States

    Description

    EC-5000 Excimer Laser Corneal Surgery System (EC-5000, EC 5000 CXIII, EC-5000 Quest. Opthalmic: NIDEK EXCIMER LASER CORNEAL SURGERY SYSTEM, model EC-5000, is an ophthalmic laser system used for correction of corneal refraction and ablation of the corneal surface.

    Reason

    Multi-stage treatment option for the EC-5000 Operator's Manual was not approved by the FDA.

    Code Info

    Alll devices currently in use by consignees.

    Distribution

    Us distribution only.

    Quantity

    114 units