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U.S. Department of Health and Human Services

Class 2 Device Recall TTDEYE (brand) Radial Brown

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  Class 2 Device Recall TTDEYE (brand) Radial Brown see related information
Date Initiated by Firm June 23, 2020
Create Date July 27, 2020
Recall Status1 Open3, Classified
Recall Number Z-2712-2020
Recall Event ID 85923
Product Classification Lenses, soft contact, daily wear - Product Code LPL
Product TTDEYE (brand) Radial Brown, B16112109 - Product Usage: Colored contact lenses
Code Information Date of manufacture: 2018-08
Recalling Firm/
Manufacturer		 Chengdu Ai Qin E-commerce Co., Ltd
N0.200, Tian Fu Fifth Street
Gao Xin China
Manufacturer Reason
for Recall		 Colored contact lenses were distributed without FDA clearance.
FDA Determined
Cause 2		 No Marketing Application
Action The firm initiated the recall by public notice on 06/23/2020 which was placed on the firm's website. The firm followed with an email notice to their consignees on 07/09/2020. The firm requested that consignees with the affected product contact the firm for return/replacement.
Distribution US Nationwide distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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