TTDEYE Devil Red Colored Contact Lenses Recalled for Lack of FDA Clearance
Chengdu Ai Qin E-commerce Co., Ltd. is recalling TTDEYE Devil Red colored contact lenses because they were distributed without FDA clearance.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device distributed without FDA clearance, which poses a risk of harm. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (Score 3).
Plain-English summary
Chengdu Ai Qin E-commerce Co., Ltd. is recalling TTDEYE (brand) Devil Red colored contact lenses, product code B16112201. The recall was initiated because the product was distributed without FDA clearance.
The affected contact lenses were manufactured in August 2018 and were distributed nationwide in the United States. The source text does not specify the exact number of units involved or report any specific illnesses or injuries associated with the product.
Consumers who possess these specific contact lenses should stop using them immediately. The source text does not provide specific instructions for disposal or return, but users should consult the manufacturer or a healthcare professional for guidance on safe handling and disposal of unapproved medical devices.
The recalled product
- Product
- TTDEYE (brand) Devil Red, B16112201 - Product Usage: Colored contact lenses
- Manufacturer
- Chengdu Ai Qin E-commerce Co., Ltd
- Category
- Medical Device — Contact Lenses
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Date of manufacture: 2018-08
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by Chengdu Ai Qin E-commerce Co., Ltd under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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