United StatesWhat's being recalled
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.
Recalling firm: CooperVision, Inc., West Henrietta, NY, United States.
How to identify it
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, 19487120027506, 19487120043038, 19487120046502, 19487120048036, 19487120051003, 19487120061007, 19487120067007, 19487120071014, 19487120075016, 19487120077016, 19487120079014, 19487120080014, 19487170006516, 19487170012505, 19487170015501, 19487170016524, 19487170017030, 19487170019503, 19487170022001, 19487170022021, 19487170023021, 19487170025011, 19487170026019, 19487170028011, 19487170028013, 19487170029019, 19487170030017, 19487170030019, 19487170031026, 19487170031028, 19487170031032…
The 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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution in the states of FL, KY, MI.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)