BEUDAMED
    FDA Enforcement Class II Ongoing

    TTDEYE (brand) Radial Brown, B16112109 - Product Usage: Colored contact lenses

    Recall: Z-2712-2020 · Reported August 5, 2020

    Enforcement

    Recall Number
    Z-2712-2020
    Event ID
    85923
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Chengdu Ai Qin E-commerce Co., Ltd
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Press Release
    Report Date
    August 5, 2020
    Initiation Date
    June 23, 2020
    Classification Date
    July 27, 2020
    Address
    N0.200, Tian Fu Fifth Street, N/A, Gao Xin, N/A, N/A, China

    Description

    TTDEYE (brand) Radial Brown, B16112109 - Product Usage: Colored contact lenses

    Reason

    Colored contact lenses were distributed without FDA clearance.

    Code Info

    Date of manufacture: 2018-08

    Distribution

    US Nationwide distribution.

    Quantity

    N/A