CooperVision, Inc. recalls Biofinity XR Toric Contact Lens

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

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.

• FDA enforcement recordOfficial FDA database entry for Z-2165-2025
• FDA device classification · LPMOfficial FDA classification for this device type
• CFR regulation · 21 CFR 886.5925The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find CooperVision, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.