BEUDAMED
    FDA Enforcement Class III Ongoing

    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 · Reported July 9, 2025

    Enforcement

    Recall Number
    Z-2046-2025
    Event ID
    96892
    Classification
    Class III
    Status
    Ongoing
    Product Type
    Devices
    Firm
    LUMITHERA INC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 9, 2025
    Initiation Date
    May 7, 2025
    Classification Date
    June 30, 2025
    Address
    19578 10th Ave Ne Ste 200, Poulsbo, WA, 98370-7332, United States

    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.

    Code Info

    Lot Code: UDI-DI +B749200001030/$$+720172/16D20250311T; Serial Number 20172 UDI-DI +B749200001030/$$+720166/16D20250311W; Serial Number 20166 UDI-DI +B749200001030/$$+720167/16D20250311X; Serial Number 20167 UDI-DI +B749200001030/$$+720168/16D20250311Y; Serial Number 20168 UDI-DI +B749200001030/$$+720169/16D20250311Z; Serial Number 20169 UDI-DI +B749200001030/$$+720175/16D20250311W; Serial Number 20175 UDI-DI +B749200001030/$$+720177/16D20250311Y; Serial Number 20177 UDI-DI +B749200001030/$$+720178/16D20250311Z; Serial Number 20178 Update 14 May 2025: UDI-DI +B749200001030/$$+720170/16D20250311R; Serial Number 20170

    Distribution

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

    Quantity

    8