BEUDAMED
    FDA Enforcement Class II Terminated

    BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584649 Ophthalmic surgical kits

    Recall: Z-1804-2015 · Reported June 24, 2015

    Enforcement

    Recall Number
    Z-1804-2015
    Event ID
    71293
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Beaver-Visitec International Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 24, 2015
    Initiation Date
    May 1, 2015
    Classification Date
    June 15, 2015
    Termination Date
    January 28, 2021
    Address
    411 Waverley Oaks Rd Ste 229, Waltham, MA, 02452-8422, United States

    Description

    BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584649 Ophthalmic surgical kits

    Reason

    Devon Light Glove in procedure kits may have holes/slits compromising sterility of the product

    Code Info

    Lot Numbers: 3039720 3046211 3047770 3049473 3070763 3082330 3089827 3093682 3095941 3106407 3117874

    Distribution

    Nationwide Distribution including KY, GA, MI, and NJ.

    Quantity

    585 kits