BEUDAMED
    FDA Enforcement Class II Terminated

    Nutrifill Scleral, Hybrid, and Gas Permeable (GP) Lens Insertion Solution, Physiologic Formula, Preservative Free, 35 Single-use 10ml ampoules (360ml), UDI:00850012123002

    Recall: Z-0030-2022 · Reported October 13, 2021

    Enforcement

    Recall Number
    Z-0030-2022
    Event ID
    88529
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Contamac Solutions, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 13, 2021
    Initiation Date
    July 27, 2021
    Classification Date
    October 5, 2021
    Termination Date
    June 7, 2023
    Address
    806 Kimball Ave, Grand Junction, CO, 81501-3842, United States

    Description

    Nutrifill Scleral, Hybrid, and Gas Permeable (GP) Lens Insertion Solution, Physiologic Formula, Preservative Free, 35 Single-use 10ml ampoules (360ml), UDI:00850012123002

    Reason

    Contact lens solution may contain foreign material

    Code Info

    Lot Number: FOE

    Distribution

    US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY. OUS: N/A

    Quantity

    104335 vials