BEUDAMED
    FDA Enforcement Class II Terminated

    BAUSCH + LOMB Biotrue ONEday lenses (nesofilcon A), Product Order Number Biotrue SVS - 7201, STERILE, Rx Only; The lenses are available in 5 pack, 30 pack and 90 pack sizes; Biotrue ONEday Foil - Part Number 8098001, Biotrue ONEday 5 pack Carton International - Part Number 8101403, and Biotrue ONEday 90 pack Carton International - Part Number 8098203.

    Recall: Z-0206-2016 · Reported November 11, 2015

    Enforcement

    Recall Number
    Z-0206-2016
    Event ID
    72161
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bausch & Lomb Inc Irb
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 11, 2015
    Initiation Date
    September 3, 2015
    Classification Date
    November 4, 2015
    Termination Date
    June 6, 2016
    Address
    1400 Goodman St N, N/A, Rochester, NY, 14609-3547, United States

    Description

    BAUSCH + LOMB Biotrue ONEday lenses (nesofilcon A), Product Order Number Biotrue SVS - 7201, STERILE, Rx Only; The lenses are available in 5 pack, 30 pack and 90 pack sizes; Biotrue ONEday Foil - Part Number 8098001, Biotrue ONEday 5 pack Carton International - Part Number 8101403, and Biotrue ONEday 90 pack Carton International - Part Number 8098203.

    Reason

    The firm determined that 25 lots had been manufactured with a minor surface defect occurring in the optical surface on each lens. Complaints of Halo or Poor Visual Acuity.

    Code Info

    Select -2.25/-3.00 Diopter Lot Numbers: W57209820 (exp. date 05/19/2019), W57210174 (exp. date 05/23/2019), W57210440 (exp. date 05/28/2019), W57211652 (exp. date 06/09/2019), W57211916 (exp. date 06/09/2019), W57212210 (exp. date 06/09/2019), W57212440 (exp. date 06/09/2019), W57212697 (exp. date 06/09/2019), W57212926 (exp. date 06/09/2019), W57213158 (exp. date 06/09/2019), W57213453 (exp. date 06/09/2019), W57213743 (exp. date 07/01/2019), W57213969 (exp. date 07/01/2019), W57214208 (exp. date 07/01/2019), W57214459 (exp. date 07/01/2019), W57214717 (exp. date 07/01/2019), W57215039 (exp. date 07/01/2019), W57215293 (exp. date 07/01/2019), W57215517 (exp. date 07/01/2019), W57215783 (exp. date 07/01/2019).

    Distribution

    Distributed US (nationwide), Canada, Japan and Thailand.

    Quantity

    Domestic: 99,260 lenses; Foreign: 84,660 lenses