BEUDAMED
    FDA Enforcement Class II Ongoing

    C-Rex UNO Microinterventional Goniotomy Instrument. Model Number: CRX-120. Product Description: The C-Rex UNO Microinterventional Goniotomy Instrument is a sterile single use disposable manual surgical instrument used in ophthalmic procedures for ab interno goniotomy and inner wall trabeculotomy.

    Recall: Z-0135-2026 · Reported October 22, 2025

    Enforcement

    Recall Number
    Z-0135-2026
    Event ID
    97640
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Iantrek Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 22, 2025
    Initiation Date
    September 6, 2025
    Classification Date
    October 10, 2025
    Address
    216 Weybosset St Ste 2, Providence, RI, 02903-3734, United States

    Description

    C-Rex UNO Microinterventional Goniotomy Instrument. Model Number: CRX-120. Product Description: The C-Rex UNO Microinterventional Goniotomy Instrument is a sterile single use disposable manual surgical instrument used in ophthalmic procedures for ab interno goniotomy and inner wall trabeculotomy.

    Reason

    Potential for compromised integrity of the sterile packaging.

    Code Info

    1. Model Number: CRX-120; UDI: +B962CRX1200/$$7351729/16D20250501/14D20260501/Q1$; Lot Number 351729; Exp date 05/2026. 2. Model Number: CRX-120 UDI: +B962CRX1200/$$7351759/16D20250501/14D20260501/Q1%; Lot Number: 351759; Exp date 05/2026.

    Distribution

    US Nationwide distribution in the states of AL, AZ, CA, CT, DE, FL, GA, ID, IL, MD, MI, MN, MO, MS, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI.

    Quantity

    198