FDAHealthAugust 22, 2025
CooperVision, Inc. — Sofmed Breathables, (stenfilcon A) contact lens. Model Number: Softmed Breathables. 54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, f
⚠️ One lot manufactured with an invalid sterilization cycle.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- August 22, 2025
US Nationwide distribution in the states of Florida, Kentucky, North Carolina, and Wisconsin.
What's affected?
- 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.
- Brand
- CooperVision, Inc.
- Lot code
- 20735504301008
Additional details
Carton Lot Number: 20735504301008. Blister Lot Number: 6450505898
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 180 units.
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