Recall archive / FDA device enforcement
Biofinity Toric Multifocal Contact Lens — FDA record Z-2166-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jun 16, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Biofinity Toric Multifocal Contact Lens
- Reason
- Lens blisters may have an incomplete or leaking seal which may render them unsterile.
- Classification
- Class II
- Recalling firm
- CooperVision, Inc.
- Quantity
- 827 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2166-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Honduras, and Mexico.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jul 30, 2025
- Recall initiation date
- Jun 16, 2025
- Center classification date
- Jul 23, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.