Biofinity XR Toric contact lens blisters may have a leaking seal
Biofinity XR Toric Contact Lenses are being recalled because lens blisters may have an incomplete or leaking seal, which may render them unsterile. 397 units are affected.
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: Risk-of-harm product: a compromised sterile barrier on a lens placed directly on the eye, with no infection reported in the source.
Plain-English summary
The Biofinity XR Toric Contact Lens is being recalled. The action covers 397 units, across the carton lot numbers listed in the recall notice including RD0226792, RD0227007, RD0227022, RD0227030, RD0227032, RD0228123 and RD0228336.
The stated reason is that lens blisters may have an incomplete or leaking seal, which may render them unsterile. The FDA classified the action as Class II. The source does not report any infection having occurred.
Distribution was worldwide, including nationwide in the United States and to Brazil, Canada and Honduras among other markets.
Wearers and eye care practitioners should identify affected stock using the carton lot numbers in the recall notice and follow the instructions issued by the manufacturer.
The recalled product
- Product
- Biofinity XR Toric Contact Lens
- Manufacturer
- CooperVision, Inc.
- Category
- Medical Device — Contact lens
- Hazard
- sterile-barrier
- leaking-seal
- blister-pack
- class-ii
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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