Device product
MyDay Toric, stenfilcon A) Contact Lens. Model/Catalog Number: MyDay Toric. 54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Disposable Wear. Blister packaged.
Z-2606-2025
Product summary
- Event
- Event 97515
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4,140 units
- Official record key
device-enforcement:Z-2606-2025
Official wording
Reason: One lot manufactured with an invalid sterilization cycle.
Code information: Carton Lot Number: 20735504301008. Blister Lot Number: 6450505898
Distribution pattern: US Nationwide distribution in the states of Florida, Kentucky, North Carolina, and Wisconsin.
Derived failure modes
-
Unknown
One lot manufactured with an invalid sterilization cycle.