BEUDAMED
    FDA Recall 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 · Initiated March 24, 2015

    Recall

    Recall Number
    Z-1710-2015
    Event Number
    71098
    Firm
    Nidek Inc
    FEI Number
    2936921
    Product Code
    LZS
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    March 24, 2015
    Posted
    June 4, 2015
    Terminated
    April 5, 2016
    Address
    47651 Westinghouse Dr, Fremont, CA, 94539-7474

    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.

    Action

    Nidek sent an Device Correction letter dated April 30th, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Nidek will contact customers to schedule an appointment to replace the operators manual and implementing a software lockout device on the device so that the multi stage feature is no longer available. If a Nidek rep does not contact you before April 30, 2015, please call 800-223-9044 to schedule an appointment, All non responding customers.will be contacted three time via Fed Ex letter

    Distribution

    Us distribution only.

    Quantity

    114 units