Generic Name: Softmed Breathables Advanced Toric (fanfilcon A) Soft (Hydrophilic) Contact Lens; Model/Catalog Number: S

Summary

The FDA issued a Class II for Generic Name: Softmed Breathables Advanced Toric (fanfilcon A) Soft (Hydrophilic by CooperVision, Inc.. Reason: The affected products bear an incorrect statement on the carton packaging indicating that the product is "Indicated for Extended Wear". However, this.

Details

Product Description

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.

Lot/Code Info: 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, 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Quantity Affected: 230856

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.

Type: Voluntary: Firm initiated

Recall Initiated: 2026-09-22

Company