Z-2165-2025 Class II Ongoing
FDA device recall Z-2165-2025 was initiated by CooperVision, Inc. on June 16, 2025 and is designated Class II. Reason for recall: Lens blisters may have an incomplete or leaking seal which may render them unsterile. The recall status is ongoing. Affected quantity: 397 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 30, 2025
- Initiation Date
- June 16, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 397 units
Product Description
Biofinity XR Toric Contact Lens
Reason for Recall
Lens blisters may have an incomplete or leaking seal which may render them unsterile.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Honduras, and Mexico.
Code Information
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.