Biofinity XR Toric Contact Lenses Recalled for Sterility Concerns
CooperVision is recalling Biofinity XR Toric contact lenses due to potential sterility issues caused by incomplete or leaking seals on lens blisters, which may introduce contamination.
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 medical devices with compromised sterility assurance. Unsterile contact lenses worn directly on the eye pose a risk-of-harm, but no illnesses or injuries have been reported. Per the severity rubric, this qualifies as High (3) based on the risk-of-harm nature of the defect despite absence of confirmed adverse events.
Plain-English summary
CooperVision, Inc. is recalling Biofinity XR Toric contact lenses due to a manufacturing defect affecting approximately 397 units with specific lot numbers. The affected lenses have been distributed worldwide, including in the United States, Brazil, Canada, Honduras, and Mexico.
Lens blisters may have incomplete or leaking seals, which may render the lenses unsterile. Unsterile contact lenses could introduce contamination to the eye.
Consumers who have purchased Biofinity XR Toric contact lenses should check whether their product matches one of the affected lot numbers listed in the FDA recall notice. If affected, they should discontinue use and contact their eye care provider or CooperVision for guidance.
The recalled product
- Product
- Biofinity XR Toric Contact Lens
- Manufacturer
- CooperVision, Inc.
- Category
- Medical Device — Contact Lenses
- Hazard
- sterility-issue
- contamination-risk
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 (20)
- Carton Lot Numbers: RD0226792
- RD0227007
- RD0227022
- RD0227030
- RD0227032
- RD0228123
- RD0228336
- RD0228465
- RD0228570
- RD0228595
- RD0228598
- RD0228603
- RD0228606
- RD0228607
- RD0228775
- RD0228778
- RD0228788
- RD0228795
- RD0228798
- RD0228799
Distribution
Distributed nationwide across the United States.
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