FDAClass IIJuly 30, 2025

Biofinity XR Toric Contact Lens recall

Biofinity XR Toric Contact Lens

Why was Biofinity XR Toric Contact Lens recalled?

Lens blisters may have an incomplete or leaking seal which may render them unsterile.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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.

Product
Biofinity XR Toric Contact Lens
Recalling firm
CooperVision, Inc.
Quantity
397 units
Distribution
Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Honduras, and Mexico.
Recall date
July 30, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls