Biofinity XR Toric Contact Lens

FDA device recall Z-2165-2025 · posted 2025-07-23 · Open, Classified

Recall details

Recalling firm

CooperVision, Inc.

Reason for recall

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

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.

Root cause

Use error

Status

Open, Classified

Product code

LPM

Quantity affected

397 units

Distribution

Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Honduras, and Mexico.

Date initiated

2025-06-16

Date posted

2025-07-23

Location

Scottsville, NY