BEUDAMED
    FDA Enforcement Class II Ongoing

    Brand Name: Tecfen Medical Product Name: 2.4mm Slit Knife, Angled Model/Catalog Number: QKN2461 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile (gamma radiation) and packaged individually in Tyvek 1059B. Slit knives are used to create precise incisions for controlled entry into the eye. Component: No

    Recall: Z-1951-2025 · Reported June 18, 2025

    Enforcement

    Recall Number
    Z-1951-2025
    Event ID
    96872
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Tecfen Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 18, 2025
    Initiation Date
    April 25, 2025
    Classification Date
    June 11, 2025
    Address
    6100 Hollister Ave # 3, Santa Barbara, CA, 93117-3272, United States

    Description

    Brand Name: Tecfen Medical Product Name: 2.4mm Slit Knife, Angled Model/Catalog Number: QKN2461 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile (gamma radiation) and packaged individually in Tyvek 1059B. Slit knives are used to create precise incisions for controlled entry into the eye. Component: No

    Reason

    Sterility assurance for Ophthalmic knives.

    Code Info

    Lot Code: Manufacture date: 2024-11-21 Expiration date: 2027-11-20 Lot number: ZGY24081907-02 UDI: 00817618021156

    Distribution

    Worldwide - US Nationwide distribution in the states of Connecticut and Minnesota. The countries of Dominican Republic, Saudi Arabia, Mexico, Chile, Iran, South Africa, Honduras, UAE, Honduras, Qatar, Iran, and Bangladesh, Brazil and Israel.

    Quantity

    115 unit