Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2714-2020Class II

TTDEYE (brand) Devil Red, B16112201 -

Chengdu Ai Qin E-commerce Co., Ltd / initiated 2020-06-23 / Open, Classified

Chengdu Ai Qin E-commerce Co., Ltd began a recall of TTDEYE (brand) Devil Red, B16112201 - Product Usage: Colored contact lenses on . FDA classified it as Class II and gives the reason as "Colored contact lenses were distributed without FDA clearance". As of , the recall status on record is Open, Classified.

Recall record

Recall number
Z-2714-2020
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Chengdu Ai Qin E-commerce Co., Ltd
Product
TTDEYE (brand) Devil Red, B16112201 - Product Usage: Colored contact lenses
Product code
LPL Lenses, Soft Contact, Daily Wear
Reason for recall
Colored contact lenses were distributed without FDA clearance.
FDA root 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.
Product codes and lots
Date of manufacture: 2018-08

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2714-2020
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2708-2020Class IIOngoingVoluntary: Firm initiated
Z-2709-2020Class IIOngoingVoluntary: Firm initiated
Z-2710-2020Class IIOngoingVoluntary: Firm initiated
Z-2711-2020Class IIOngoingVoluntary: Firm initiated
Z-2712-2020Class IIOngoingVoluntary: Firm initiated
Z-2713-2020Class IIOngoingVoluntary: Firm initiated
Z-2714-2020Class IIOngoingVoluntary: Firm initiated