TTDEYE Flower Grey Colored Contact Lenses Recalled for Lack of FDA Clearance
Chengdu Ai Qin E-commerce Co., Ltd is recalling TTDEYE Flower Grey 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The source text does not report any specific injuries, illnesses, or fatalities, and the hazard is primarily regulatory (lack of clearance) rather than a confirmed physical defect causing harm.
Plain-English summary
Chengdu Ai Qin E-commerce Co., Ltd is recalling TTDEYE (brand) Flower Grey colored contact lenses, model B16112231. The recall is being conducted because the product was distributed without FDA clearance.
The affected units have a date of manufacture of 2018-08. The product was distributed nationwide in the United States.
Consumers should stop using the product immediately and contact the recalling firm for instructions on how to return the product or obtain a refund.
The recalled product
- Product
- TTDEYE (brand) Flower Grey, B16112231 - Product Usage: Colored contact lenses
- Manufacturer
- Chengdu Ai Qin E-commerce Co., Ltd
- Category
- Medical Device — Contact Lenses
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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