BEUDAMED
    FDA Enforcement Class II Ongoing

    Orascoptic Superior Visualization Custom loupes configured with Phantom Frames

    Recall: Z-2441-2025 · Reported September 3, 2025

    Enforcement

    Recall Number
    Z-2441-2025
    Event ID
    97260
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Orascoptic Surgical Acuity
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 3, 2025
    Initiation Date
    July 3, 2025
    Classification Date
    August 26, 2025
    Address
    717 W Collins Ave, Orange, CA, 92867-5513, United States

    Description

    Orascoptic Superior Visualization Custom loupes configured with Phantom Frames

    Reason

    Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.

    Code Info

    All serial numbers manufactured between June 6, 2023 - May 14, 2025

    Distribution

    Worldwide - US Nationwide distribution including in the states of AK, AL, AP, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WI, WV, WY and the countries of AE, AT, AU, BR, CA , CH, CZ, DE, DZ, EE, ES, FI, FR, GB, GR, HR, HU, IE, IL, IT, JP, KW, KY, LT, MA, MY, NL, NO, NZ, PL, PR, PT, RO, SE, SG, SK, TR.

    Quantity

    10,611 units