Z-2708-2020 Class II Ongoing
FDA device recall Z-2708-2020 was initiated by Chengdu Ai Qin E-commerce Co., Ltd on June 23, 2020 and is designated Class II. Reason for recall: Colored contact lenses were distributed without FDA clearance. The recall status is ongoing. Affected quantity: N/A.
Recall Details
- Product Type
- Devices
- Report Date
- August 5, 2020
- Initiation Date
- June 23, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
TTDEYE (brand) Black Starshine, B16112100 - Product Usage: Colored contact lenses
Reason for Recall
Colored contact lenses were distributed without FDA clearance.
Distribution Pattern
US Nationwide distribution.
Code Information
Date of manufacture: 2018-08