TTDEYE Black Starshine Colored Contact Lenses Recalled for Lack of FDA Clearance
Chengdu Ai Qin E-commerce Co., Ltd is recalling TTDEYE Black Starshine colored contact lenses because they were distributed without FDA clearance.
What this means for you
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 (contact lenses) distributed without FDA clearance, representing a risk-of-harm product where injury has not yet been reported, which aligns with the 'High' severity criteria.
Plain-English summary
Chengdu Ai Qin E-commerce Co., Ltd is recalling TTDEYE (brand) Black Starshine, B16112100 colored contact lenses. The recall was initiated because the product was distributed without FDA clearance.
The affected units were manufactured in August 2018 and were distributed nationwide in the United States. The source text does not specify the exact number of units recalled or report any specific illnesses or injuries associated with the product.
Consumers who possess these specific colored contact lenses should stop using them immediately. The recall is based on regulatory non-compliance regarding FDA clearance rather than a reported safety incident.
The recalled product
- Product
- TTDEYE (brand) Black Starshine, B16112100 - 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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