Device product
TTDEYE (brand) Black Starshine, B16112100 - Product Usage: Colored contact lenses
Z-2708-2020
Product summary
- Event
- Event 85923
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-2708-2020
Official wording
Reason: Colored contact lenses were distributed without FDA clearance.
Code information: Date of manufacture: 2018-08
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Colored contact lenses were distributed without FDA clearance.