FDAFDA · Food and drugs·Recall number Z-2165-2025
Biofinity XR Toric Contact Lens
Published July 30, 2025 · Recall initiated: June 16, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lens blisters may have an incomplete or leaking seal which may render them unsterile.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- CooperVision, Inc.
- Distributor
- Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Honduras, and Mexico.
- Lot
- Carton Lot Numbers: RD0226792, RD0227007, RD0227022, RD0227030, RD0227032, RD0228123, RD0228336, RD0228465, RD0228570, RD0228595, RD0228598, RD0228603, RD0228606, RD0228607, RD0228775, RD0228778, RD0228788, RD0228795, RD0228798, RD0228799, RD0228802, RD0228809, RD0228814, RD0228825, RD0228835, RD0228840, RD0228842, RD0228847, RD0228853, RD0228854, RD0228855, RD0228866, RD0228875, RD0228876, RD0228940, RE0152731, RE0152735, RE0152737, RE0152740, RE0152743, RE0152744, RE0152755, RE0152760, RE0152775, RE0152799, RE0152838, RE0152871, RE0152873, RE0152877, RE0152883, RE0152889, RE0152891, RE0152913, RE0152915, RE0152917, RE0153804, RE0153819, RE0153924, RE0153974, RE0154076, RE0154085, RE0154095, RE0154100, RE0154103, RE0154105, RE0154107, RE0154113, RE0154114, RE0154117, RE0154137, RE0154139, RE0154143, RE0154253, RE0154256, RE0154259, RE0154264, RE0154271, RE0154329.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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