CooperVision Biofinity XR Toric lenses recalled for manufacturing misalignment
CooperVision is recalling Biofinity XR Toric contact lenses manufactured with misaligned axis, resulting in incorrect lens power and 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 is an FDA Class II recall of a medical device with a direct manufacturing defect causing functional harm (incorrect lens power leading to poor visual acuity). No hospitalizations, deaths, or reported illnesses have been documented, but the hazard is not theoretical. This meets the rubric criterion for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
CooperVision, Inc. is recalling Biofinity XR Toric Single Diagnostic soft contact lenses (extended wear) due to a manufacturing defect. The affected lenses were manufactured with a misaligned axis, resulting in incorrect optical power.
Consumers wearing these lenses may experience poor visual acuity. The recalled product was distributed nationwide in California, Ohio, North Carolina, and Pennsylvania. Affected lot numbers are R24395839, R24406094, and R24409954.
If you have lenses from the affected lots, contact CooperVision or your eye care provider. Do not use recalled lenses; continue using your previous corrective lenses or consult your eye care provider for alternatives. Seek medical attention if you experience vision problems related to these lenses.
The recalled product
- Product
- Biofinity XR Toric Single Diagnostic lens- Soft (hydrophilic) Contact Lens (extended wear)
- Manufacturer
- CooperVision, Inc.
- Category
- Medical Device — Contact Lenses
- Hazard
- refractive-error
- 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 (3)
- UDI: N/A Lot Numbers: R24395839
- R24406094
- R24409954
Distribution
Distributed nationwide across the United States.
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