Recall Z-2165-2025— CooperVision, Inc.

Name: FDA recall Z-2165-2025
Creator: U.S. Food and Drug Administration
Published: 2025-06-16

Class II · Ongoing

Class II FDA medical device recall by CooperVision, Inc., initiated 2025-06-16. FDA's recall record names no specific 510(k) clearance for this event. Product: Biofinity XR Toric Contact Lens. Reason: Lens blisters may have an incomplete or leaking seal which may render them unsterile..

Recalling firm: CooperVision, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-06-16
Firm location: Scottsville, NY, United States

Product description

Biofinity XR Toric Contact Lens

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.