Recall Z-2165-2025
CooperVision, Inc. · initiated June 16, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Biofinity XR Toric Contact Lens
Codes / lots: 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.
Reason for recall
Lens blisters may have an incomplete or leaking seal which may render them unsterile.
FDA-determined cause: Use error
Action taken
An URGENT MEDICAL DEVICE CORRECTION notice dated 6/27/25 was mailed to distributors, retailers, and physicians notifying them of this recall. The notification instructs consignees to inspect their inventory for affected devices and stop any further distribution/sale of affected devices. Practitioners are instructed to share the provided Consumer Communication Letter with any patients who received affected devices and to have patients return any units in their possession for replacement or credit. Consignees are to dispose of any affected product in their inventory or that is returned. Consignees are to complete and return the provided Correction Response Form via fax to 888-385-3217 or by email at info@coopervision.com. Consignees with any complaints can contact the Customer Care Team at 855-526-6737; questions about this recall action can be directed to Customer Service at 800-341-2020.
Details
- Recall number
- Z-2165-2025
- Initiated
- June 16, 2025
- Posted by FDA
- July 23, 2025
- Product code
- LPM – Lenses, Soft Contact, Extended Wear
- Quantity
- 397 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Honduras, and Mexico.
- Recalling firm
- CooperVision, Inc., Scottsville, NY
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2166-2025 Class II | Biofinity Toric Multifocal Contact LensLens blisters may have an incomplete or leaking seal which may render them unsterile. | 06/16/2025Open, Classified |