CooperVision CLARITI 1 DAY TORIC contact lenses recalled for axis misalignment
CooperVision is recalling CLARITI 1 DAY TORIC contact lenses (Lot W0106186) due to misaligned placement of the axis mark, which can cause blurred vision.
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: This is a Class II medical device recall involving a manufacturing defect that causes blurred vision. No illnesses or injuries have been reported; the hazard is a functional impairment rather than a high-risk contamination or serious safety concern.
Plain-English summary
CooperVision Inc. is recalling CLARITI 1 DAY TORIC Power -07.00 -1.25/010 daily disposable contact lenses with UV blocker due to misaligned placement of an axis mark. This defect can cause patients to experience blurred vision.
The affected product is Lot W0106186, consisting of 450 lenses. Distribution includes US states: Florida, New York, Tennessee, Ohio, North Carolina, and Wisconsin. International distribution includes France, United Arab Emirates, Brazil, Australia, New Zealand, Taiwan, and Canada.
Patients using this product should discontinue use and contact their eye care provider or CooperVision for a replacement.
The recalled product
- Product
- CLARITI 1 DAY TORIC Power -07.00 -1.25/010 Daily Disposable Contact Lens with UV blocker
- Manufacturer
- CooperVision Inc.
- Category
- Medical Device — Contact Lenses
- Affected units
- 450
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)
- Lot Number: W0106186
Distribution
Part of a larger recall action
This product is one of 12 recalled by CooperVision Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 12 products in this recall →Related recalls
Same manufacturer · CooperVision Inc.
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Same hazard · axis misalignment
See all →- HighContact Lens Recall: Misaligned Axis Mark May Cause Blurred Vision
FDA (Devices) · 2021-08-04
- HighContact Lens Axis Mark Misalignment May Cause Blurred Vision
FDA (Devices) · 2021-08-04
- ModerateContact Lens Axis Mark Misalignment Causes Blurred Vision
FDA (Devices) · 2021-08-04
- HighContact lens recall: misaligned axis mark may cause blurred vision
FDA (Devices) · 2021-08-04
- HighCooperVision CLARITI 1 DAY TORIC contact lenses recalled for axis mark misalignment
FDA (Devices) · 2021-08-04
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