Z-0206-2016Class II

BAUSCH + LOMB Biotrue ONEday lenses (nesofilcon A), Product Order Number Biotrue SVS - 7201, STERILE, Rx...

Name: Z-0206-2016 BAUSCH + LOMB Biotrue ONEday lenses (nesofilcon A), Product Order Number Biotrue SVS - 7201, STERILE, Rx...
Creator: Bausch & Lomb Inc Irb
Published: 2015-09-03
License: https://open.fda.gov/license/

Bausch & Lomb Incorporated / initiated 2015-09-03 / Terminated / root cause: manufacturing process

FDA source

Bausch & Lomb Inc Irb began a recall of 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... on 2015-09-03. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0206-2016
Classification: Class II
Status: Terminated
Initiated: 2015-09-03
Posted: 2015-11-04
Terminated: 2016-06-06
Recalling firm: Bausch & Lomb Incorporated
Product: 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.
Product code: LPL Lenses, Soft Contact, Daily Wear
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: Domestic: 99,260 lenses; Foreign: 84,660 lenses
Distribution: Distributed US (nationwide), Canada, Japan and Thailand.
Product codes and lots: 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).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0206-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0206-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-11	2015-11-04

Product code LPL

K113703Class IIBausch + Lomb Nesofilcon a Contact LensBausch & Lomb, Incorporated / cleared 2012-06-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)