Cooper Vision Recalls Soft Contact Lenses Due to Incorrect Lens Axis
Cooper Vision Caribbean Corp. is recalling 1,170 soft contact lenses because portions of the lots may contain units with an incorrect lens axis condition.
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 manufacturing defect (incorrect lens axis) without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Cooper Vision Caribbean Corp. is recalling 1,170 units of Soft Contact Lenses. The recall affects Lots # 8246525202 and # 8255525096, which were distributed nationwide in the United States.
The recall was initiated because portions of the lots may contain units with an incorrect lens axis condition. This defect could result in improper fit or vision correction for the wearer.
Consumers who possess these specific lots should stop using the contact lenses and contact the recalling firm for instructions on how to return or dispose of the product.
The recalled product
- Product
- Soft Contact Lens
- Manufacturer
- Cooper Vision Caribbean Corp.
- Category
- Medical Device — Contact Lenses
- Hazard
- Affected units
- 1,170
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)
- Lots # 8246525202 & 8255525096
Distribution
Distributed nationwide across the United States.
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