The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0206-2016·Announced 2015-11-11

Bausch + Lomb Recalls Biotrue ONEday Lenses Due to Surface Defects

Bausch + Lomb is recalling Biotrue ONEday contact lenses because a manufacturing defect on the lens surface may cause visual disturbances like halos or poor vision.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source describes the defect as 'minor' and the resulting issues as visual disturbances (halos/poor acuity) rather than physical injury or hospitalization, fitting the Moderate criteria for low-risk issues without reported severe harm.

Plain-English summary

Bausch + Lomb Inc Irb is recalling specific lots of Biotrue ONEday lenses (nesofilcon A) due to a minor surface defect on the optical surface of the lenses. The defect was identified in 25 lots and is associated with complaints of halos or poor visual acuity.

The affected lenses are sterile, prescription-only daily wear contact lenses available in 5, 30, and 90 pack sizes. The recall covers specific lot numbers for -2.25 and -3.00 Diopter lenses with expiration dates ranging from May to July 2019. The firm determined that these defects occurred during the manufacturing process.

The affected units were distributed nationwide in the United States, as well as in Canada, Japan, and Thailand. Consumers who have these specific lenses should stop using them and contact Bausch + Lomb or their eye care professional for instructions on how to return the product for a refund or replacement.

The recalled product

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…
Manufacturer
Bausch & Lomb Inc Irb
Category
Medical Device — Contact Lenses
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distributed nationwide across the United States.

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