CooperVision, Inc. recalls Generic Name: Softmed Breathables Advanced Toric
- Recalling company
- CooperVision, Inc.
- 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
- 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 – may cause temporary or medically reversible health consequences
- Recall date
- Sep 22, 2026
- Reported
- Oct 28, 2026
- Distribution
- US Nationwide distribution in the states of FL, KY, MI.
- Status
- Ongoing
- Quantity
- 230856
- Lot / 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, 19486170042032, 19486170043003, 19486170043028, 19486170043030, 19486170043032, 19486170043502, 19486170044017, 19486170045011, 19486170047002, 19486170047007, 19486170047011, 19486170048011, 19486170049004, 19486170049006, 19486170049009, 19486170049011, 19486170050003, 19486170050004, 19486170050007, 19486170050019, 19486170051002, 19486170051006, 19486170051024, 19486170052002, 19486170052005, 19486170052009, 19486170052015, 19486170053015, 19486170053024, 19486170054015, 19486170054016, 19486170055000, 19486170055018, 19486170055026, 19486170056000, 19486170056014, 19486170057005, 19486170059018, 19486170060008, 19486170060012, 19486170060014, 19486170061008, 19486170061014, 19486170061018, 19486170064014, 19486170065008, 19486170068010, 19486170069010, 19487120020526, 19487120026512, 194871200
- Company location
- West Henrietta, NY
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0204-2027
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0204-2027 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.