BEUDAMED
    FDA Enforcement Class II Ongoing

    TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only,

    Recall: Z-1033-2022 · Reported May 11, 2022

    Enforcement

    Recall Number
    Z-1033-2022
    Event ID
    89991
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Johnson & Johnson Surgical Vision Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 11, 2022
    Initiation Date
    April 6, 2022
    Classification Date
    May 4, 2022
    Address
    1700 E Saint Andrew Pl, N/A, Santa Ana, CA, 92705-4933, United States

    Description

    TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only,

    Reason

    Potential breach in the sterility barrier for tray ring covers.

    Code Info

    All Lots within Expiry: GTIN:05050474520707

    Distribution

    Worlwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, HI, IL, IN, KS, MA, MD, MN, MO, NC, NE, NJ, NM, NV, NY, OH, OR, PA, TN, TX, WA, WI and the countries of Chile, Indonesia, India, Japan, Malaysia, Philippines, Taiwan.

    Quantity

    N/A