Z-2165-2025Class II

Biofinity XR Toric Contact Lens

Name: Z-2165-2025 Biofinity XR Toric Contact Lens
Creator: CooperVision, Inc.
Published: 2025-06-16
License: https://open.fda.gov/license/

CooperVision, Inc. / initiated 2025-06-16 / Open, Classified / root cause: sterility

FDA source

CooperVision, Inc. began a recall of Biofinity XR Toric Contact Lens on 2025-06-16. FDA classified it as Class II and gives the reason as "Lens blisters may have an incomplete or leaking seal which may render them unsterile". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-2165-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-06-16
Posted: 2025-07-23
Recalling firm: CooperVision, Inc.
Product: Biofinity XR Toric Contact Lens
Product code: LPM Lenses, Soft Contact, Extended Wear
Reason for recall: Lens blisters may have an incomplete or leaking seal which may render them unsterile.
Root cause tag: sterility
FDA root cause: Use error
Action: 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 [email protected]. 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.
Quantity in commerce: 397 units
Distribution: Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Honduras, and Mexico.
Product codes and 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2165-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2165-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-30	2025-07-23
Z-2166-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-30	2025-07-23

Product code LPM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)