BEUDAMED
    FDA Enforcement Class II Ongoing

    Brand Name: Tecfen Medical Product Name: 2.0mm Crescent Knife Angled Bevel Up Model/Catalog Number: QKN1010 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile and packaged individually in Tyhvek 1059B. The crescent knife is used to create smooth, curved incisions for corneal transplant procedures, used in small incision cataract surgery and phacoemulsification to create self-sealing scleral tunnels, used for creating tunnel incisions in the sclera and cornea during procedures like trabeculectomy. Component: No

    Recall: Z-1954-2025 · Reported June 18, 2025

    Enforcement

    Recall Number
    Z-1954-2025
    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: 2.0mm Crescent Knife Angled Bevel Up Model/Catalog Number: QKN1010 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile and packaged individually in Tyhvek 1059B. The crescent knife is used to create smooth, curved incisions for corneal transplant procedures, used in small incision cataract surgery and phacoemulsification to create self-sealing scleral tunnels, used for creating tunnel incisions in the sclera and cornea during procedures like trabeculectomy. Component: No

    Reason

    Sterility assurance for Ophthalmic knives.

    Code Info

    Lot Code: Manufacture date: 2024-11-22 Expiration date: 2027-11-21 Lot number: ZGY24071501-03 UDI: 00817618021330

    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

    42 units