BEUDAMED
    FDA Recall Terminated

    YC-1800 OPHTHALMIC YAG LASER SYSTEM; The YC-1800 allows the safe and bloodless treatment of intraocular diseases for outpatients by mechanical disruption caused by energy of the YAG laser pulses.

    Recall: Z-1367-2015 · Initiated March 6, 2015

    Recall

    Recall Number
    Z-1367-2015
    Event Number
    70571
    Firm
    Nidek Inc
    FEI Number
    2936921
    Product Code
    LXS
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 6, 2015
    Posted
    April 2, 2015
    Terminated
    September 3, 2015
    Address
    47651 Westinghouse Dr, Fremont, CA, 94539-7474

    Description

    YC-1800 OPHTHALMIC YAG LASER SYSTEM; The YC-1800 allows the safe and bloodless treatment of intraocular diseases for outpatients by mechanical disruption caused by energy of the YAG laser pulses.

    Reason

    Dear Doctor letter and Quick Reference Guide is being sent to users of the YC-1800 to reiterate important safety and cleaning information after complaints of pitting lens that may cause unclear images.

    Action

    Dear Doctor letters were sent along with a Quick Reference guide to all affected sites in February.

    Distribution

    Nationwide Distribution.

    Quantity

    799 units