BEUDAMED
    FDA Enforcement Class II Terminated

    AERO IOL Injection System containing 10 Z28 Cartridges per box, Part #003500-0025-282, Sterile, Rx. The firm name on the label is Aaren Scientific Inc., Ontario, CA. Used to fold and insert the firm's IOL's.

    Recall: Z-0071-2018 · Reported November 15, 2017

    Enforcement

    Recall Number
    Z-0071-2018
    Event ID
    78037
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Aaren Scientific Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    November 15, 2017
    Initiation Date
    September 1, 2017
    Classification Date
    November 8, 2017
    Termination Date
    May 1, 2018
    Address
    1040 S Vintage Ave Ste A, N/A, Ontario, CA, 91761-3631, United States

    Description

    AERO IOL Injection System containing 10 Z28 Cartridges per box, Part #003500-0025-282, Sterile, Rx. The firm name on the label is Aaren Scientific Inc., Ontario, CA. Used to fold and insert the firm's IOL's.

    Reason

    The recommended storage temperature on the label is incorrect.

    Code Info

    Lot numbers and expiration dates: 160204, 1/31/2018; 160505, 4/30/2018; 161006, 9/30/2018; 161018, 9/30/2018; 161028, 9/30/2018; 161219, 11/30/2018; and 170120, 12/31/2018.

    Distribution

    Nationwide distribution including Puerto Rico.

    Quantity

    786 boxes