BEUDAMED
    FDA Recall Open, Classified

    Brand Name: Valeda Light Delivery System Product Name: Light Based Device for Dry Age Related Macular Degeneration Product Description: Light Based Device for Dry Age Related Macular Degeneration Component: No

    Recall: Z-2046-2025 · Initiated May 7, 2025

    Recall

    Recall Number
    Z-2046-2025
    Event Number
    96892
    Firm
    LUMITHERA INC
    FEI Number
    3016232028
    Product Code
    SDE
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    May 7, 2025
    Posted
    June 30, 2025
    Address
    19578 10th Ave Ne, Ste 200, Poulsbo, WA, 98370-7332

    Description

    Brand Name: Valeda Light Delivery System Product Name: Light Based Device for Dry Age Related Macular Degeneration Product Description: Light Based Device for Dry Age Related Macular Degeneration Component: No

    Reason

    U.S. customers were shipped devices that were configured for the European Union and were unable to plug the device in the electrical outlet.

    Action

    On 05/08/2025, the firm initiated sending customers an "Valeda - Return" email to inform them that the Valeda system that was distributed to them was sent with the wrong configuration. Customer were instructed to use the attached return label and return the systems back to LumiThera.

    Distribution

    US Nationwide distribution in the states of AZ, CA, FL, IL, ND, TN, TX.

    Quantity

    8