FDA-Device2025-10-01Class II
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.
Hazard
One lot manufactured with an invalid sterilization cycle.
Sold states
US Nationwide distribution in the states of Florida, Kentucky, North Carolina, and Wisconsin.
Affected count
180 units
Manufactured in
180 Thruway Park Dr, N/A, West Henrietta, NY, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2607-2025Want us to check the next one for you?
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