Reported Oct 1, 2025 · Ongoing
Sofmed Breathables, (stenfilcon A) contact lens. Model Number: Softmed Breathables. 54% water content, Toric, cast…
CooperVision, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: CooperVision, Inc. · 180 Thruway Park Dr · West Henrietta, NY · 14586-9798
Is this the product you have?
- Sofmed Breathables, (stenfilcon A) contact lens
- Model NumberSoftmed Breathables. 54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Disposable Wear. Blister packaged
- Lot codes and dates
- Carton Lot Number20735504301008
- Blister Lot Number6450505898
- Amount recalled
- 180 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
One lot manufactured with an invalid sterilization cycle.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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