CooperVision Biofinity XR Toric Contact Lenses: Risk of Unsterile Lenses
CooperVision recalls Biofinity XR Toric Contact Lenses with specific lot numbers due to potential incomplete seals that could make lenses unsterile. Consumers should check their carton lot numbers to see if they are affected.
Lower-risk recall
Lens blisters may have an incomplete or leaking seal which may render them unsterile.
Contact the company
What happened, in plain English
CooperVision is recalling Biofinity XR Toric Contact Lenses with certain lot numbers because the lenses might have seals that don't close properly, making them unsterile. This could lead to eye infections or other infections if used. Read more at govinfonow.com/recall/52035-coopervision-biofinity-xr-toric-contact-lenses-risk-of-unsterile-lenses.
Source Summary by GovInfoNow · govinfonow.com/recall/52035-coopervision-biofinity-xr-toric-contact-lenses-risk-of-unsterile-lenses · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2165-2025
Cite this page
“CooperVision Biofinity XR Toric Contact Lenses: Risk of Unsterile Lenses.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/52035-coopervision-biofinity-xr-toric-contact-lenses-risk-of-unsterile-lenses. Based on FDA recall #Z-2165-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2165-2025%22&limit=1).
Why it’s dangerous
The lenses may have incomplete or leaking seals, which can compromise their sterility. If the lenses are not sterile, using them could lead to eye infections or other infections.
Who’s affected
People who own or use Biofinity XR Toric Contact Lenses with the listed carton lot numbers are affected. Those with sensitive eyes or who use lenses frequently are at slightly higher risk.
How to tell if you have this one
Check the carton lot numbers on your Biofinity XR Toric Contact Lens packaging. The affected lot numbers are listed in the recall notice, including RD0226792 and RE0152731 among others.
- Brand
CooperVision- Category
Medical device
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 countries of Brazil, Canada, Honduras, and Mexico.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2165-2025 | Biofinity XR Toric Contact Lens; Carton Lot Numbers: RD0226792, RD0227007, RD0227022, RD0227030, RD0227032, RD0228123, RD0228336, RD0228465, RD0228570, RD0228595, RD0228598, RD0228603, RD0228606, RD0228607, RD0228775, RD0228778, RD0228788, RD0228795, RD0228798, RD0228799, RD0228802, RD0228809, RD0228814, RD0228825, RD0228835, RD0228840, RD0228842, RD0228847, RD0228853, RD0228854, RD0228855, RD0228866, RD0228875, RD0228876, RD0228940, RE0152731, RE0152735, RE0152737, RE0152740, RE0152743, RE0152744, RE0152755, RE0152760, RE0152775, RE0152799, RE0152838, RE0152871, RE0152873, RE0152877, RE0152883, RE0152889, RE0152891, RE0152913, RE0152915, RE0152917, RE0153804, RE0153819, RE0153924, RE0153974, RE0154076, RE0154085, RE0154095, RE0154100, RE0154103, RE0154105, RE0154107, RE0154113, RE0154114, RE0154117, RE0154137, RE0154139, RE0154143, RE0154253, RE0154256, RE0154259, RE0154264, RE0154271, RE0154329. | 397 units |
| Z-2166-2025 | Biofinity Toric Multifocal Contact Lens; Carton Lot Numbers: RB0682365, RB0684301, RB0684305, RB0684311, RB0684313, RB0684317, RB0684321, RB0684325, RB0684335, RB0684506, RB0684575, RB0684582, RB0684653, RB0684657, RB0684659, RB0684663, RB0684664, RB0684667, RB0684668, RB0684669, RB0684670, RB0684673, RB0684674, RB0684676, RB0684682, RB0686359, RB0687092, RB0687368, RB0687370, RB0687547, RB0687582, RB0687586, RB0687665, RB0687693, RB0687797, RB0687800, RB0687801, RB0687802, RB0687803, RB0687807, RB0687812, RB0687822, RB0687893, RB0687897, RB0687904, RB0687908, RB0687910, RB0687922, RB0688105, RB0688107, RB0688109, RB0688113, RB0688117, RB0688121, RB0688128, RB0688130, RB0688145, RB0688147, RB0688151, RB0688163, RB0688170, RB0688174, RB0688269, RB0688298, RB0688300, RB0688305, RB0688307, RB0688320, RB0688322, RB0688343, RB0688492, RC1756323, RC1759660, RC1759663, RC1759931, RC1759947, RC1759965, RC1759967 | 827 units |
What to do — step by step
Check Carton Lot Numbers
Look for the lot numbers on the carton of your Biofinity XR Toric Contact Lenses to see if they match the affected list.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Honduras, and Mexico.” 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 44 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-2165-2025 (June 16, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2165-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 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.