Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience poor visual acuity
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📍Recalling firmCooperVision, Inc.180 Thruway Park Dr · West Henrietta, NY 14586-9798
✎ GovInfoNow plain-language explainer
CooperVision, Inc. is recalling approximately 2,443 Biofinity Toric Multifocal soft contact lenses because they were manufactured with a misaligned axis. This defect results in lenses having incorrect power, which may cause users to experience poor visual acuity. The affected lenses are distributed nationwide in the U.S. and in Canada. Read more at govinfonow.com/recall/54149-coopervision-biofinity-toric-multifocal-lenses-recall-incorrect-power-may-cause.
“CooperVision Recalls Biofinity Toric Lenses for Incorrect Power.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/54149-coopervision-biofinity-toric-multifocal-lenses-recall-incorrect-power-may-cause. Based on FDA recall #Z-3311-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3311-2024%22&limit=1).
The FDA announced on Aug. 29, 2024, that CooperVision, Inc. is recalling Biofinity Toric Multifocal Contact Lenses due to a manufacturing defect. The lenses may have an incorrect power because of a misaligned axis, potentially causing poor visual acuity for users.
Lot Numbers: RB0444532 through RB0451666, RC1241675 through RC1253124
The hazard
According to the FDA, the recalled lenses were manufactured with a misaligned axis, resulting in incorrect power. This defect may cause users to experience poor visual acuity.
Context
GovInfoNow's records show CooperVision has 11 other recalls on record since Sept. 1, 2017. Other recent recalls include CooperVision Pearle Vision 1 Day Contact Lenses (Aug. 12, 2026) and CooperVision MyDay Toric Contact Lenses (Aug. 22, 2025).
How to tell if you have this one
Check your contact lens packaging for the lot numbers listed in the record, which range from RB0444532 to RC1253124. The product is identified as Biofinity Toric Multifocal Soft Contact Lenses indicated for the correction of ametropia (myopia or hyperopia with astigmatism) with presbyopia.
Brand
CooperVision
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
FDA distribution: “Worldwide distribution - US Nationwide and the country of Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 41 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-3311-2024 (August 29, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3311-2024 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 13, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.