Z-2166-2025 Class II Ongoing
FDA device recall Z-2166-2025 was initiated by CooperVision, Inc. on Jun 16, 2025 and is designated Class II. Reason for recall: Lens blisters may have an incomplete or leaking seal which may render them unsterile. The recall status is ongoing. Affected quantity: 827 units.
Recall details
- Product Type
- Devices
- Report Date
- Jul 30, 2025
- Initiation Date
- Jun 16, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 827 units
Product description
Biofinity Toric Multifocal Contact Lens
Reason for recall
Lens blisters may have an incomplete or leaking seal which may render them unsterile.
Distribution pattern
Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Honduras, and Mexico.
Code information
Carton Lot Numbers: RB0682365, RB0684301, RB0684305, RB0684311, RB0684313, RB0684317, RB0684321, RB0684325, RB0684335, RB0684506, RB0684575, RB0684582, RB0684653, RB0684657, RB0684659, RB0684663, RB0684664, RB0684667, RB0684668, RB0684669, RB0684670, RB0684673, RB0684674, RB0684676, RB0684682, RB0686359, RB0687092, RB0687368, RB0687370, RB0687547, RB0687582, RB0687586, RB0687665, RB0687693, RB0687797, RB0687800, RB0687801, RB0687802, RB0687803, RB0687807, RB0687812, RB0687822, RB0687893, RB0687897, RB0687904, RB0687908, RB0687910, RB0687922, RB0688105, RB0688107, RB0688109, RB0688113, RB0688117, RB0688121, RB0688128, RB0688130, RB0688145, RB0688147, RB0688151, RB0688163, RB0688170, RB0688174, RB0688269, RB0688298, RB0688300, RB0688305, RB0688307, RB0688320, RB0688322, RB0688343, RB0688492, RC1756323, RC1759660, RC1759663, RC1759931, RC1759947, RC1759965, RC1759967
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2166-2025
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026