BEUDAMED
    FDA Enforcement Class II Ongoing

    bvi CustomEyes Kit-AMO Germany GmbH Katarakt-set - Dr. Wagner: CustomEyes Cataract Surgical Kits that contain Beaver Xstar¿ Crescent Knife (REF#373809) as a component a) REF# 588221 REF#: 373809

    Recall: Z-0228-2022 · Reported November 24, 2021

    Enforcement

    Recall Number
    Z-0228-2022
    Event ID
    88826
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Beaver Visitec International, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 24, 2021
    Initiation Date
    October 8, 2021
    Classification Date
    November 16, 2021
    Address
    500 Totten Pond Rd, 10 City Point, Waltham, MA, 02451-1916, United States

    Description

    bvi CustomEyes Kit-AMO Germany GmbH Katarakt-set - Dr. Wagner: CustomEyes Cataract Surgical Kits that contain Beaver Xstar¿ Crescent Knife (REF#373809) as a component a) REF# 588221 REF#: 373809

    Reason

    Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades

    Code Info

    Lot Numbers 3296729, 3299124, 3305081, 3307565, 3312464, 3324620, 6033588. UDI: " Primary: 00886158112839 " Secondary: 30886158112830 " Tertiary: 50886158112834

    Distribution

    Nationwide Foreign: Australia Austria France Germany Netherlands Spain Japan Russia South Africa UK

    Quantity

    500 eaches