FDA recall Z-2165-2025

CooperVision, Inc. · Class II · device

Product

Biofinity XR Toric Contact Lens

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.

Key facts

Status: Ongoing
Initiation date: 2025-06-16
Report date: 2025-07-30
Voluntary/Mandated: Voluntary: Firm initiated
Location: Scottsville, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2165-2025