Bausch & Lomb Inc Irb: Medical Device Recall in 2015 - (Recall #: Z-0206-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: September 3, 2015

Date Posted: November 11, 2015

Recall Number: Z-0206-2016

Event ID: 72161

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.

Status: Terminated

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

Code Information:

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 Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated