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CooperVision, Inc. recalls Sofmed Breathables, (stenfilcon A) contact lens. Model Number: Softmed Breathables. 54% water content, Toric, cast mo
Recalled October 1, 2025 · FDA recall Z-2607-2025 · CooperVision
Hazard
One lot manufactured with an invalid sterilization cycle. · FDA Class II
Units
180 units
Sold at
US Nationwide distribution in the states of Florida, Kentucky, North Carolina, and Wisconsin.
Description
One lot manufactured with an invalid sterilization cycle.
Product
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.
Manufacturer(s)
CooperVision, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →