Contact Lens Recall: Misaligned Axis Mark May Cause Blurred Vision
CooperVision is recalling CLARITI 1 DAY TORIC contact lenses with misaligned axis marks that may cause blurred vision. The defective lenses were distributed worldwide including multiple U.S. states.
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: FDA Class II medical device recall where the defect directly impacts the product's intended use by causing blurred vision. This qualifies as a risk-of-harm product where no illnesses or injuries have been reported.
Plain-English summary
CooperVision Inc. is recalling CLARITI 1 DAY TORIC daily disposable contact lenses with Power -07.50, cylinder -0.75, and axis 060 due to a manufacturing defect.
A misaligned placement of the axis mark on affected lenses can cause patients to experience blurred vision. The axis mark alignment is critical to providing correct vision correction.
The affected product (lot number R0121629, 90-lens packages) was distributed worldwide, including in the United States in Florida, New York, Tennessee, Ohio, North Carolina, and Wisconsin, as well as internationally in France, the United Arab Emirates, Brazil, Australia, New Zealand, Taiwan, and Canada.
Patients who have received affected lenses should contact their eye care provider regarding this recall.
The recalled product
- Product
- CLARITI 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposable Contact Lens with UV blocker
- Manufacturer
- CooperVision Inc.
- Category
- Medical Device — Contact Lenses
- Affected units
- 90
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: R0121629
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 · vision defect
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FDA (Devices) · 2021-08-04
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