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Recall Observatory FDA recall evidence

Device 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.

Z-0206-2016

September 03, 2015

Class II

Product summary

Firm
Bausch & Lomb Inc Irb
Event
Event 72161
Status
Terminated
Classification
Class II
Quantity
Domestic: 99,260 lenses; Foreign: 84,660 lenses
Official record key
device-enforcement:Z-0206-2016

Official wording

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 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.