Clerio Vision Recalls Extreme H2O 59% Contact Lenses for Mislabeled Power
Clerio Vision is recalling 153 Extreme H2O 59% contact lenses because they may be mislabeled with the incorrect lens power.
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, and the hazard involves a labeling error (incorrect lens power) without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Clerio Vision is recalling 153 units of Extreme H2O 59% (hioxifilcon A) spherical soft contact lenses for daily wear. The recall was initiated because the lenses may be mislabeled with the incorrect lens power.
The affected lenses are identified by Lot Number 0114511565. The product was distributed worldwide, including in the United States (Illinois and Missouri) and in Denmark, Germany, The Netherlands, and Switzerland.
Consumers should stop using the recalled lenses and contact Clerio Vision for further instructions.
The recalled product
- Product
- EXTREME H2O 59% (hioxifilcon A) spherical soft contact lens for daily wear - Product Usage: indicated for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit…
- Manufacturer
- Clerio Vision
- Category
- Medical Device — Contact Lenses
- Hazard
- Affected units
- 153
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 (3)
- Lot Number: 0114511565
- UPC Code: 675506700657 (6 pack)
- 675506668650 (individual)
Distribution
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