Class II

Medical Device Recall: Biofinity XR Toric Contact Lens

CooperVision, Inc. · June 16, 2025

Reason for Recall

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

Distribution

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

States Affected

NATIONWIDE

Quantity Affected

397 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2165-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.