Contact Lenses Recalled for Potential Health Risk

Summary
Company Announcement Date:
June 24, 2020
FDA Publish Date:
June 24, 2020
Product Type:
Medical Devices
Reason for Announcement:
Distributed without FDA clearance may pose health risk
Company Name:
Chengdu Ai Qin E-commerce Co., Ltd
Brand Name:
TTDeye
Product Description:
Colored contact lenses
Company Announcement
On June 18, 2020, Chengdu Ai Qin E-commerce Co., Ltd initiated a nationwide recall of 1362 pairs of colored contact lenses. The relevant series of contact lenses have been found to be distributed without FDA clearance and may pose a threat to health.

The following products are being recalled:

Name of Product

Black Starshine

Diamonds Starlight

Flower Brown

Flower Grey

Radial Brown

Radial Pink

Devil Red

Brand TTDeye TTDeye TTDeye TTDeye TTDeye TTDeye TTDeye
Lot Codes B16112100 B16112203 B16112210 B16112231 B16112109 B16112110 B16112201
These colored contact lenses were sold through the website www.ttdeye.comExternal Link Disclaimer and shipped directly to the customer from 08/05/2019 – 10/11/2019.

The recalled products were manufactured August 2018 and may be identified by name of the product and the date of manufacture, “2018-08”, found on the package label.

If you have received this product, immediately cease use and contact the company via online chat at www.ttdeye.comExternal Link Disclaimer between 9AM and 6PM (GMT+8) or contact the company via email at info@ttdeye.com (24 hours) for further information.

The company has received no complaints to date.

Chengdu Ai Qin E-commerce Co., Ltd is notifying its customers by email and is arranging for return/replacement of all recalled colored contact lenses.

Chengdu Ai Qin E-commerce Co., Ltd is voluntarily recalling these contact lenses after becoming aware of the problem. Chengdu Ai Qin E-commerce Co., Ltd has notified the FDA of this action.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online
Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the full FDA report here.
As published by HealthyExaminer.com