Contact Lenses Recalled for Misaligned Axis Causing Poor Vision
CooperVision is recalling Biofinity XR Toric contact lenses due to misaligned axis in manufacturing that results in incorrect lens power. Users may experience poor visual acuity.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This recall involves a manufacturing defect in a medical device affecting vision—a risk-of-harm product category. However, no reported injuries, illnesses, or hospitalizations are documented in the source. As an FDA Class II recall with no adverse health outcomes reported, this meets the criteria for High severity.
Plain-English summary
CooperVision, Inc. is recalling Biofinity XR Toric 6-pack soft contact lenses (extended wear) due to a manufacturing defect.
The affected lenses were manufactured with a misaligned axis, resulting in lenses with incorrect optical power. Users of these lenses may experience poor visual acuity.
The recall affects lenses distributed across the United States in California, Ohio, North Carolina, and Pennsylvania. The affected lot numbers are: R24377024, R24377026, R24381716, R24416900.
Consumers should stop using these contact lenses and consult their eye care provider for replacement lenses. The FDA classified this as a Class II recall.
The recalled product
- Product
- Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear)
- Manufacturer
- CooperVision, Inc.
- Affected units
- 24
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 (4)
- UDI: N/A Lot Numbers: R24377024
- R24377026
- R24381716
- R24416900
Distribution
Part of a larger recall action
This product is one of 2 recalled by CooperVision, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · CooperVision, Inc.
See all →- HighVoyant daily toric contact lenses recalled over an invalid sterilization cycle
FDA (Devices) · 2025-10-01
- HighSofmed Breathables contact lenses recalled over an invalid sterilization cycle
FDA (Devices) · 2025-10-01
- HighMyDay toric contact lenses recalled after one lot used invalid sterilization
FDA (Devices) · 2025-10-01
- HighBiofinity XR Toric contact lens blisters may have a leaking seal
FDA (Devices) · 2025-07-30
- HighBiofinity Toric Multifocal contact lens blisters may have a leaking seal
FDA (Devices) · 2025-07-30
Same hazard · optical defect
See all →- HighOculus Pentacam AXL optical devices recalled for measurement accuracy issues
FDA (Devices) · 2023-09-06
- ModerateAbbott Alinity Reaction Vessels Recalled for Potential Contaminant
FDA (Devices) · 2023-01-25
- HighLeica Surgical Operating Microscopes recalled for illumination adjustment defect
FDA (Devices) · 2022-10-05