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.
- Hazard
- optical-defect
- vision-impairment
- manufacturing-defect
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
Distributed nationwide across the United States.
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