Biofinity Toric Multifocal Contact Lens Recalled for Potential Sterility Issues
CooperVision is recalling Biofinity Toric Multifocal Contact Lenses with potentially compromised blister seals that may render the lenses unsterile. Approximately 827 units are affected worldwide.
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 FDA Class II recall involves a risk-of-harm product (contact lenses that may be unsterile) with no reported illnesses or injuries. Unsterile contact lenses pose a potential risk of serious eye infection.
Plain-English summary
CooperVision, Inc. is recalling specific lot numbers of Biofinity Toric Multifocal Contact Lenses distributed worldwide. Approximately 827 units are affected by this recall.
The recall was initiated because lens blisters may have incomplete or leaking seals, which may render the lenses unsterile. Unsterile contact lenses pose a risk of serious eye infections and other complications.
The affected contact lenses were distributed worldwide, including across the United States and in Brazil, Canada, Honduras, and Mexico. Consumers who have purchased these lenses should check if their product's lot number matches those identified in the recall.
If you have a recalled lot number, you should discontinue use of the affected lenses immediately and contact your eye care provider for guidance on replacement or alternative contact lens options.
The recalled product
- Product
- Biofinity Toric Multifocal Contact Lens
- Manufacturer
- CooperVision, Inc.
- Category
- Medical Device — Contact Lenses
- Hazard
- unsterile
- seal-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 (20)
- Carton Lot Numbers: RB0682365
- RB0684301
- RB0684305
- RB0684311
- RB0684313
- RB0684317
- RB0684321
- RB0684325
- RB0684335
- RB0684506
- RB0684575
- RB0684582
- RB0684653
- RB0684657
- RB0684659
- RB0684663
- RB0684664
- RB0684667
- RB0684668
- RB0684669
Distribution
Distributed nationwide across the United States.
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