Cooper Vision Recalls ProClear Toric Contact Lenses for Axis Defect
Cooper Vision is recalling ProClear Toric contact lenses because routine quality monitoring found that some lots were manufactured with the cylinder axis outside allowable specifications.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 III, which by definition is unlikely to cause adverse health consequences. The defect is a manufacturing specification issue (cylinder axis) rather than a direct safety hazard like contamination or structural failure, fitting the criteria for a moderate severity score.
Plain-English summary
Cooper Vision Caribbean Corp. is recalling ProClear Toric contact lenses. The company's routine quality monitoring system identified that a limited number of lots were manufactured with the cylinder axis outside the allowable specification.
The affected lenses are made from a material containing 62% water and 38% omafilcon B, a random copolymer of 2-hydroxyethylmethacrylate and methacrylic acid. They feature a VAT Blue 6 tint to make the lens more visible for handling. The recall involves 13,639 lenses across 246 product lots.
The product was distributed nationwide in the US and internationally to Canada, Latin America, the EU, Asia Pacific, and Africa/Central Eurasia countries. Consumers should stop using the affected lenses and contact their eye care professional or the manufacturer for instructions.
The recalled product
- Product
- ProClear Toric contact lenses are made from a material containing 62% water and 38% omafilcon B, a random copolymer of 2-hydroxyethylmethacrylate and methacrylic acid. The lenses have a tint (VAT Blue 6) which is added to make the lens more visible for handling.
- Manufacturer
- Cooper Vision Caribbean Corp.
- Category
- Medical Device — Contact Lenses
- Hazard
Distribution
Distributed nationwide across the United States.
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