Recall of Biotrue ONEday (nesofilcon A) lenses

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bausch & Lomb Inc Irb.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    72161
  • Event Risk Class
    Class 2
  • Event Number
    Z-0206-2016
  • Event Initiated Date
    2015-09-03
  • Event Date Posted
    2015-11-04
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2016-06-06
  • Event Source
    USFDA
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Lenses, soft contact, daily wear - Product Code LPL
  • 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 BLCustomerCare@bausch.com. Customers may also contact Bausch + Lomb Customer Service at 1-800-828-9030 to arrange return of affected product.

Device

  • Model / Serial
    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).
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed US (nationwide), Canada, Japan and Thailand.
  • Product 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.
  • Manufacturer

Manufacturer

  • Manufacturer Address
    Bausch & Lomb Inc Irb, 1400 Goodman St N, Rochester NY 14609-3547
  • Manufacturer Parent Company (2017)
  • Source
    USFDA