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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 397
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.
Part of a larger recall action
This product is one of 2 recalled by CooperVision, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · CooperVision, Inc.
See all →- ModerateCooperVision Recalls Pearle Vision 1 Day Contact Lenses Due to Incorrect Power
FDA (Devices) · 2026-09-30
- HighSofmed Breathables contact lenses recalled over an invalid sterilization cycle
FDA (Devices) · 2025-10-01
- HighVoyant daily toric contact lenses recalled over an invalid sterilization cycle
FDA (Devices) · 2025-10-01
- HighMyDay toric contact lenses recalled after one lot used invalid sterilization
FDA (Devices) · 2025-10-01
- HighBiofinity Toric Multifocal contact lens blisters may have a leaking seal
FDA (Devices) · 2025-07-30
Same hazard · sterile barrier
See all →- HighSplashwire hydrophilic guide wire pouches have unsealed portions
FDA (Devices) · 2026-06-24
- HighCovidien EndoStitch loading unit pouches may have sterility-breaking holes
FDA (Devices) · 2026-06-10
- HighReprocessed electrophysiology catheters recalled over incomplete sterile seals
FDA (Devices) · 2026-05-20
- HighMediHoney wound gel recalled over potential packaging failures
FDA (Devices) · 2026-02-25
- HighCatheter cutdown trays recalled over damage to the outer tray
FDA (Devices) · 2026-02-25
Similar recalls
- HighContact Lenses Recalled for Misaligned Axis Causing Poor Vision
FDA (Devices) · 2023-03-08
- LowCooperVision Recalls Biofinity XR Toric Contact Lenses Due to Labeling Error
FDA (Devices) · 2018-03-07
- HighCooperVision Biofinity XR Toric lenses recalled for manufacturing misalignment
FDA (Devices) · 2023-03-08
- HighMyDay toric contact lenses recalled after one lot used invalid sterilization
FDA (Devices) · 2025-10-01
- HighBIOFINITY XR TORIC Contact Lenses Recalled for Misaligned Axis Defect
FDA (Devices) · 2024-10-09
- HighVoyant daily toric contact lenses recalled over an invalid sterilization cycle
FDA (Devices) · 2025-10-01