CLARITI 1 DAY TORIC Contact Lenses Recalled Due to Axis Mark Misalignment
CooperVision is recalling CLARITI 1 DAY TORIC contact lenses (Lot W0106167) due to misaligned axis marks that can cause blurred vision. Affected patients should discontinue use and contact their eye care provider.
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: This is an FDA Class II recall involving a medical device with a manufacturing defect that directly causes vision impairment. Although no illnesses or injuries have been reported, the defect creates a genuine risk of harm to patient safety, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
CooperVision Inc. is recalling CLARITI 1 DAY TORIC Daily Disposable Contact Lenses with UV blocker due to a manufacturing defect. Misaligned placement of the axis mark—which indicates proper lens orientation for astigmatism correction—can cause patients to experience blurred vision.
The recall affects Lot Number W0106167, distributed in the United States (Florida, New York, Tennessee, Ohio, North Carolina, and Wisconsin) and internationally (France, United Arab Emirates, Brazil, Australia, New Zealand, Taiwan, and Canada).
Patients using lenses from this lot should discontinue use and contact their eye care provider for replacement lenses or alternatives. No illnesses or injuries have been reported to date.
The recalled product
- Product
- CLARITI 1 DAY TORIC -DIAGNOSTIC Power-07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker
- Manufacturer
- CooperVision Inc.
- Affected units
- 10
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: W0106167
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
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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
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- HighContact lens recall: misaligned axis mark may cause blurred vision
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