BEUDAMED
    FDA Recall 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 · Initiated September 3, 2015

    Recall

    Recall Number
    Z-0206-2016
    Event Number
    72161
    Firm
    Bausch & Lomb Inc Irb
    FEI Number
    1317628
    Product Code
    LPL
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    September 3, 2015
    Posted
    November 4, 2015
    Terminated
    June 6, 2016
    Address
    1400 Goodman St N, Rochester, NY, 14609-3547

    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.

    Action

    On 9/3/2015, the distributors received the Medical Device Recall Letter (dated 9/2/2015) via e-mail. Medical Device Recall Letters (dated 9/2/2015) and Customer Acknowledgement Cards were hand delivered to the direct customers via Bausch + Lomb Sales Representatives starting on 9/14/2015 or sent via FedEx if consignee is not a B+L account. The letter informs the accounts of the recall and instructs them to direct any consumers who would like to report a product complaint, arrange for a product exchange, or obtain more information on the product recall to contact the Bausch + Lombs Consumer Affairs Team at 1-800-553-5340 or via e-mail at [email protected]. Customers may also contact Bausch + Lomb Customer Service at 1-800-828-9030 to arrange return of affected product.

    Distribution

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

    Quantity

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