BEUDAMED
    FDA Enforcement Class II Ongoing

    ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery.

    Recall: Z-1007-2022 · Reported May 4, 2022

    Enforcement

    Recall Number
    Z-1007-2022
    Event ID
    89928
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Carl Zeiss Meditec AG
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    May 4, 2022
    Initiation Date
    March 16, 2022
    Classification Date
    April 26, 2022
    Address
    Rudolf-Eber-Str. 11, Oberkochen, N/A, Germany

    Description

    ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery.

    Reason

    High friction of the slider can cause the device to stick, or not move as intended.

    Code Info

    Model: 303071-9090-000 Catalog Number: FG-50608 UDI: (01)04049539104496(11)201102(17)231031(10)FG21082410 Lot Number: FG21082410

    Distribution

    U.S.: AL, AR, AZ, CA, CT, FL, GA, IA, IL, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NJ, NY, OH, OR, PA, Puerto Rico, SC, TN, TX. UT, VA, WA, and WV O.U.S.: Not provided

    Quantity

    1225 devices