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FDA Medical Device Recalls (openFDA)

Chengdu Ai Qin E-commerce Co., Ltd: TTDEYE (brand) Black Starshine, B16112100 - Product Usage: Colored contact lenses

Recall number
Z-2708-2020
Recalling firm
Chengdu Ai Qin E-commerce Co., Ltd
Product
TTDEYE (brand) Black Starshine, B16112100 - Product Usage: Colored contact lenses
Status
Open, Classified
Initiated
2020-06-23
Posted
not on file
Terminated
not on file
Reason
Colored contact lenses were distributed without FDA clearance.
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.
Quantity
not on file
Distribution
US Nationwide distribution.
Lot, serial or model codes
Date of manufacture: 2018-08
510(k) numbers
not on file
PMA numbers
not on file
Product code
LPL
Firm FEI
3017032169
Firm city
Gao Xin
Firm state
not on file
Firm country
China

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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