BEUDAMED
    FDA Enforcement Class II Terminated

    REFRESH CONTACTS¿ Contact Lens Comfort Drops 0.4 fl oz (12 mL) Sterile

    Recall: Z-0948-2021 · Reported February 10, 2021

    Enforcement

    Recall Number
    Z-0948-2021
    Event ID
    87058
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Allergan PLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 10, 2021
    Initiation Date
    December 29, 2020
    Classification Date
    February 3, 2021
    Termination Date
    March 23, 2023
    Address
    2525 Dupont Dr, Irvine, CA, 92612-1531, United States

    Description

    REFRESH CONTACTS¿ Contact Lens Comfort Drops 0.4 fl oz (12 mL) Sterile

    Reason

    Missing Instruction For Use insert.

    Code Info

    Model Number: 91822US UDI Code: (01)00300231822120(17)230705(10)T0464A Lot Number: T0464A

    Distribution

    U.S.: MO O.U.S.: None

    Quantity

    24 units