BEUDAMED
    FDA Enforcement Class II Ongoing

    GEO-MED CATARACT PACK, REF 89-5790.08

    Recall: Z-0709-2023 · Reported December 21, 2022

    Enforcement

    Recall Number
    Z-0709-2023
    Event ID
    91134
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    DeRoyal Industries Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    December 21, 2022
    Initiation Date
    November 3, 2022
    Classification Date
    December 15, 2022
    Address
    200 Debusk Ln, N/A, Powell, TN, 37849-4703, United States

    Description

    GEO-MED CATARACT PACK, REF 89-5790.08

    Reason

    XXX

    Code Info

    Lot Numbers: 55966890 exp 02/01/2023; 56020131 exp 03/01/2023; 56184435 exp 02/01/2023; 56618387 exp 06/01/2023; 57001493 exp 06/01/2023; 57227821 exp 09/01/2023; 57466709 exp 09/01/2023; 57589522 exp 09/01/2023; 57749750 exp 12/01/2023; 5786389 ezp 12/01/2023

    Distribution

    US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

    Quantity

    834 kits