CooperVision recalls Softmed Breathables Advanced Toric contact lenses over wrong extended wear label on carton
The cartons wrongly say the lenses are "Indicated for Extended Wear", but they are meant for daily wear and the FDA has not approved them for extended wear use.
What to do
The notice does not give instructions. Read the official notice for details.
Do not stop taking a prescribed medicine, or stop using a device you rely on, until you have talked to your pharmacist or doctor.
Recall details
- Product
- Generic Name: Softmed Breathables Advanced Toric (fanfilcon A) Soft (Hydrophilic) Contact Lens; Model/Catalog Number: Softmed Breathables Advanced Toric Product Description: 55% water content, toric, silicone hydrogel contact lens for daily wear, frequent replacement. Blister packaged.
- Company
- CooperVision, Inc.
- Hazard
- The affected products bear an incorrect statement on the carton packaging indicating that the product is "Indicated for Extended Wear". However, this product is intended for daily wear, and the extended-wear statement should not have appeared on the affected carton labeling. This product is not approved by the U.S. Food and Drug Administration (FDA) for extended wear use.
- Units
- 230856
- Where sold
- US Nationwide distribution in the states of FL, KY, MI.
- FDA classification
- Class II · Ongoing
- Classified by FDA
- October 22, 2026
- Recall started
- September 22, 2026
- FDA enforcement report
- October 28, 2026
- Identifiers
- Codes: Model/Catalog Number: Softmed Breathables Advanced Toric; UDI-DI: N/A Lot numbers: 19486120027517, 19486120030515, 19486120035532, 19486120051506, 19486170015507, 19486170016513, 19486170016521, 19486170017507, 19486170017509, 19486170017512, 19486170019512, 19486170019514, 19486170021021, 19486170021518, 19486170022503, 19486170022504, 19486170023528, 19486170025508, 19486170026021, 19486170027034, 19486170027504, 19486170027524, 19486170028518, 19486170030023, 19486170030034, 19486170031023, 19486170031034, 19486170032030, 19486170032036, 19486170032504, 19486170033501, 19486170034001, 19486170034032, 19486170034038, 19486170039040, 19486170040030, 19486170041032, 19486170042018…
- FDA recall number: Z-0204-2027
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- Product
- Generic Name: Softmed Breathables Advanced Toric (fanfilcon A) Soft (Hydrophilic) Contact Lens; Model/Catalog Number: Softmed Breathables Advanced Toric Product Description: 55% water content, toric, silicone hydrogel contact lens for daily wear, frequent replacement. Blister packaged.
- Reason for recall
- The affected products bear an incorrect statement on the carton packaging indicating that the product is "Indicated for Extended Wear". However, this product is intended for daily wear, and the extended-wear statement should not have appeared on the affected carton labeling. This product is not approved by the U.S. Food and Drug Administration (FDA) for extended wear use.
- Classification
- Class II (Ongoing)
- Distribution
- US Nationwide distribution in the states of FL, KY, MI.
- Quantity
- 230856
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