BEUDAMED
    FDA Enforcement Class II Terminated

    Alcon Single-Use Curved Jewelers/Iris Bipolar Forceps REF 8065129101 Sterile RX only; Alcon Single-Use Straight/Iris Bipolar Forceps REF 8065129501 Sterile RX only. Usage: Electrosurgical instrument for ophthalmic surgery.

    Recall: Z-0527-2015 · Reported December 17, 2014

    Enforcement

    Recall Number
    Z-0527-2015
    Event ID
    69743
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Alcon Research, Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 17, 2014
    Initiation Date
    November 11, 2014
    Classification Date
    December 8, 2014
    Termination Date
    February 4, 2016
    Address
    6201 South Fwy, N/A, Fort Worth, TX, 76134-2099, United States

    Description

    Alcon Single-Use Curved Jewelers/Iris Bipolar Forceps REF 8065129101 Sterile RX only; Alcon Single-Use Straight/Iris Bipolar Forceps REF 8065129501 Sterile RX only. Usage: Electrosurgical instrument for ophthalmic surgery.

    Reason

    The product is sold and labeled as EO sterilized, however the units were not sterilized prior to shipment to customers.

    Code Info

    Lot numbers 061814-95 and 080614-91

    Distribution

    Worldwide distribution: US (nationwide) and countries of: Indonesia, South Africa, Switzerland, Brazil, Kazakhstan, and Pakistan.

    Quantity

    2321