See Clear Company Recalls Color Contact Lenses for Sterility and Labeling Issues
The See Clear Company is recalling 119,829 units of color contact lenses because they may not be sterile and may have incorrect lot numbers or expiry dates.
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 is classified as FDA Class II. The hazard involves potential lack of sterility in medical devices, which poses a risk of harm, but the source text does not report specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
The See Clear Company is recalling 119,829 units of color contact lenses sold under the brands Diamond, Fierce, Ambition, Circle Collection, Lunatic, Fright, Desire, and See Clear. The recall was initiated because the lenses may not be sterile and may be labeled with erroneous lot numbers and expiry dates.
The affected lenses were sold between October 31, 2013, and October 31, 2016. Distribution was worldwide, including nationwide distribution in the United States and in Canada. Specific US states listed include Arizona, California, Delaware, Florida, Georgia, Hawaii, Louisiana, New Jersey, New York, Nevada, Ontario, Pennsylvania, and Washington.
Consumers should stop using these contact lenses immediately. The FDA classifies this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Color contact lenses labeled under the following brands: Diamond, Fierce, Ambition, Circle Collection, Lunatic, Fright, Desire and See Clear.
- Manufacturer
- The See Clear Company
- Category
- Medical Device — Contact Lenses
- Hazard
- Affected units
- 119,829
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 lots of lenses sold between 10/31/2013 to 10/31/2016
Distribution
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