Sofmed Breathables, (stenfilcon A) contact lens. Model Number: Softmed Breathables. 54% water ...
FDA Recall #Z-2607-2025 — Class II — August 22, 2025
Product Description
Sofmed Breathables, (stenfilcon A) contact lens. Model Number: Softmed Breathables. 54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Disposable Wear. Blister packaged.
Reason for Recall
One lot manufactured with an invalid sterilization cycle.
Recalling Firm
CooperVision, Inc. — West Henrietta, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
180 units
Distribution
US Nationwide distribution in the states of Florida, Kentucky, North Carolina, and Wisconsin.
Code Information
Carton Lot Number: 20735504301008. Blister Lot Number: 6450505898
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated