BEUDAMED
    FDA Enforcement Class II Ongoing

    CustomEyes kits

    Recall: Z-1200-2023 · Reported March 8, 2023

    Enforcement

    Recall Number
    Z-1200-2023
    Event ID
    91488
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Beaver Visitec International, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 8, 2023
    Initiation Date
    December 20, 2022
    Classification Date
    March 1, 2023
    Address
    500 Totten Pond Rd, 10 City Point, Waltham, MA, 02451-1916, United States

    Description

    CustomEyes kits

    Reason

    Device packaging may contain open seals, compromising product sterility.

    Code Info

    Catalog #BVI-58001086 and BVI-58001089, Lot Numbers 6051841, 6052299, 6051842, 6052300 UDI/DI: 50886158021990 and 50886158021969

    Distribution

    US distribution in AL, CA, CO, DC, FL, GA, IL, LA, MD, MN, MT, NC, NH, NJ, NM, NY, OH OK, PA, RI, TN, TX, UT, VA, VT, WA, and WI OUS distribution to Canada, Japan, and South Africa

    Quantity

    4640 units in total