Biofinity Toric Multifocal contact lens blisters may have a leaking seal
Biofinity Toric Multifocal Contact Lenses are being recalled because lens blisters may have an incomplete or leaking seal, which may render them unsterile. 827 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 Toric Multifocal Contact Lens is being recalled. The action covers 827 units, across the carton lot numbers listed in the recall notice including RB0682365, RB0684301, RB0684305, RB0684311, RB0684313, RB0684317 and RB0684321.
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 Toric Multifocal 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: 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.
Related recalls
Same category
- SevereT-Lok Bone Marrow Tray Kits Recalled for Sterility Testing Failure
FDA (Devices) · 2026-07-22
- SevereMedtronic Bio-Medicus Adult Cannula Kit Recalled for Foreign Material
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Introducer Kit heart pump accessory recall
FDA (Devices) · 2026-07-22
- HighOlympus Toomey Evacuator 50cc with Adaptor sterilization recall
FDA (Devices) · 2026-07-22
- HighVasoview Hemopro 2 Endoscopic Vessel Harvesting System Recall
FDA (Devices) · 2026-07-22