Z-2607-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 1, 2025
- Initiation Date
- August 22, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 180 units
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.
Distribution Pattern
US Nationwide distribution in the states of Florida, Kentucky, North Carolina, and Wisconsin.
Code Information
Carton Lot Number: 20735504301008. Blister Lot Number: 6450505898