BEUDAMED
    FDA Enforcement Class II Ongoing

    MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic knife, used with Suction Set, Part: 48-1000-01

    Recall: Z-0411-2026 · Reported November 5, 2025

    Enforcement

    Recall Number
    Z-0411-2026
    Event ID
    97470
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MicroSurgical Technology Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 5, 2025
    Initiation Date
    August 20, 2025
    Classification Date
    October 29, 2025
    Address
    8415 154th Ave Ne, N/A, Redmond, WA, 98052-6482, United States

    Description

    MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic knife, used with Suction Set, Part: 48-1000-01

    Reason

    An ophthalmic knife has a suction set (not direct patient-contacting), which contains springs contaminated with an unidentified residue that may potentially cause eye irritation

    Code Info

    UDI:00844685014316. Lots: 207552 and 208238

    Distribution

    US Nationwide distribution in the state of GA.

    Quantity

    8