BEUDAMED
    FDA Enforcement Class II Ongoing

    Brand Name: Contour Product Name: Contour Gold Eyelid Weight Model/Catalog Number: LL3010 Product Description: Contour Gold Eyelid Weight, 1.0 gm MedDev Contour and ThinProfile Eyelid Weight Implants are designed for the gravity-assisted treatment of protracted permanent lagophthalmos, usually resulting from facial paralysis.

    Recall: Z-1744-2025 · Reported May 21, 2025

    Enforcement

    Recall Number
    Z-1744-2025
    Event ID
    96551
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Meddev Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 21, 2025
    Initiation Date
    July 12, 2024
    Classification Date
    May 9, 2025
    Address
    730 N Pastoria Ave, Sunnyvale, CA, 94085-3522, United States

    Description

    Brand Name: Contour Product Name: Contour Gold Eyelid Weight Model/Catalog Number: LL3010 Product Description: Contour Gold Eyelid Weight, 1.0 gm MedDev Contour and ThinProfile Eyelid Weight Implants are designed for the gravity-assisted treatment of protracted permanent lagophthalmos, usually resulting from facial paralysis.

    Reason

    Due to mislabeling of products

    Code Info

    Model No LL3010; UDI code: 010081314202038217260727107227 Lot Number: 7227

    Distribution

    U.S. Nationwide distribution in the states of CA, CO, CT, FL, IA, IL, MA, ME, MI, NE, NY, OH, OK, OR, SC, TX, and WV.

    Quantity

    34 weights