Class 2 Device Recall TTDEYE (brand) Flower Brown

• Date Initiated by Firm: June 23, 2020
• Create Date: July 27, 2020
• Recall Status: Open, Classified
• Recall Number: Z-2710-2020
• Recall Event ID: 85923
• Product Classification: Lenses, soft contact, daily wear - Product Code LPL
• Product: TTDEYE (brand) Flower Brown, B16112210 - 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: 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.