24K Premium Contact Lenses Recalled Due to Potential Bacterial Contamination
Ontact Inc. is recalling 24K Premium contact lenses distributed in California and Nevada due to potential bacterial contamination.
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: This is a risk-of-harm medical device where injury has not yet been reported. Bacterial contamination of contact lenses poses a meaningful risk of infection, and the FDA's Class II classification confirms the agency's concern, but the absence of reported illnesses or injuries means this does not meet the threshold for Severe (4) or Critical (5).
Plain-English summary
Ontact Inc. is recalling 24K Premium contact lenses due to potential bacterial contamination. The recalled product was distributed nationwide in California and Nevada, affecting approximately 2,842 units.
Contact lenses are medical devices that come into direct contact with the eye. Bacterial contamination of these lenses poses a risk of infection. The FDA classified this recall as Class II based on the potential health risk.
The recalled product
- Product
- 24K Premium Lense, Distributed by Updream Inc.
- Manufacturer
- Ontact Inc
- Category
- Medical Device — Contact Lenses
- Affected units
- 2,842
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)
- All distributed lenses.
Distribution
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