“CooperVision Biofinity XR Toric Contact Lenses: Incorrect Power Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59002-coopervision-biofinity-xr-toric-contact-lenses-incorrect-power-risk. Based on FDA recall #Z-1197-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1197-2023%22&limit=1).
The FDA announced on Jan. 26, 2023, that CooperVision, Inc. is recalling Biofinity XR Toric 6-pack- Soft contact lenses due to manufacturing defects. The lenses may have the incorrect power because of a misaligned axis. Owners should contact the company for a remedy.
Lot Numbers: R24377024, R24377026, R24381716, R24416900
Distribution: US Nationwide in CA, OH, NC, PA
The hazard
The lenses were manufactured with a misaligned axis, resulting in incorrect power. Users may experience poor visual acuity as a result.
Context
GovInfoNow's records show CooperVision has 11 other recalls since Sept. 1, 2017. Other recent recalls include the Aug. 12, 2026 recall of Pearle Vision 1 Day Contact Lenses for incorrect power risk and the Aug. 22, 2025 recall of MyDay Toric Contact Lenses for an invalid sterilization cycle risk. On June 16, 2025, CooperVision also recalled Biofinity XR Toric Contact Lenses due to the risk of unsterile lenses.
How to tell if you have this one
Check the lot numbers on the packaging: R24377024, R24377026, R24381716, or R24416900. These are the affected models sold by CooperVision.
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
US Nationwide distribution in the states of CA, OH, NC, PA.
Biofinity XR Toric Single Diagnostic lens- Soft (hydrophilic) Contact Lens (extended wear); UDI: N/A Lot Numbers: R24395839, R24406094, R24409954
4 units
Based on the official FDA remedy
What to do — step by step
Check Lot Numbers
Look for lot numbers R24377024, R24377026, R24381716, or R24416900 on the packaging.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 4 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of CA, OH, NC, PA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, North Carolina, Ohio, Pennsylvania.
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-1197-2023 (January 26, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1197-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.