BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-0411-2026 · Initiated August 20, 2025

    Recall

    Recall Number
    Z-0411-2026
    Event Number
    97470
    Firm
    MicroSurgical Technology Inc
    FEI Number
    3019924
    Product Code
    HNN
    Status
    Open, Classified
    Root Cause
    Material/Component Contamination
    Initiated
    August 20, 2025
    Posted
    October 29, 2025
    Address
    8415 154th Ave Ne, Redmond, WA, 98052-6482

    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

    Action

    On 8/20/2025, a recall notice was sent to a surgery center that was asked to return the affected devices and provide information on affected device disposition. The customer was also asked, if they further distributed affected devices, to notify their customers of the recall For additional information, contact the firm at [email protected]

    Distribution

    US Nationwide distribution in the state of GA.

    Quantity

    8