BEUDAMED
    FDA Recall Open, Classified

    Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 17188-04, 19762-03, 19203-04, 19203-04, 17957-10 Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A

    Recall: Z-0939-2026 · Initiated November 24, 2025

    Recall

    Recall Number
    Z-0939-2026
    Event Number
    98055
    Firm
    Alcon Research LLC
    FEI Number
    1610287
    Product Code
    LRO
    Status
    Open, Classified
    Root Cause
    Packaging
    Initiated
    November 24, 2025
    Posted
    December 23, 2025
    Address
    6201 South Fwy Fort, Worth, TX, 76134-2099

    Description

    Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 17188-04, 19762-03, 19203-04, 19203-04, 17957-10 Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A

    Reason

    Ophthalmic procedure packs may have incomplete seals affecting sterility.

    Action

    On November 24, 2025, Alcon issued a Urgent Medical Device Notification to affected consignees. Alcon ask affected consignees to take the following actions: 1. Review your inventory to determine if you have any unused affected product within your facility. 2. Segregate and dispose of any unused affected product from your inventory. 3. Call Alcon Customer Service to arrange for replacement of your affected inventory of Alcon Custom Pak. 4. Respond to Alcon indicating your understanding of these instructions. 5. Please forward this notification to all departments within your organization who may be in possession of this affected product; and any other organization to which this product may have been transferred.

    Distribution

    US Nationwide distribution in the states of CA, ND, UT.

    Quantity

    151 units