CooperVision CLARITI Contact Lenses Recalled for Misaligned Axis Marks
CooperVision is recalling CLARITI 1 DAY TORIC contact lenses (Lot U0108940) because misaligned axis marks can cause blurred vision in patients.
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 device recall for a manufacturing defect that poses a risk to patient vision. Misaligned axis marks can cause blurred vision in toric lens wearers. No injuries or illnesses have been reported, placing this in the "risk-of-harm products where injury has not yet been reported" criterion.
Plain-English summary
CooperVision Inc. is recalling CLARITI 1 DAY TORIC daily disposable contact lenses with UV blocker due to a manufacturing defect.
Specifically, misaligned placement of the axis mark on the lens can cause patients to experience blurred vision. The recalled lot is U0108940, which includes 1260 lenses.
The affected lenses were distributed worldwide and in the United States across Florida, New York, Tennessee, Ohio, North Carolina, and Wisconsin, as well as internationally in France, United Arab Emirates, Brazil, Australia, New Zealand, Taiwan, and Canada.
Patients who use these lenses should discontinue use and contact their eye care provider. CooperVision and health care providers have been notified of this recall.
The recalled product
- Product
- CLARITI 1 DAY TORIC Power -07.00 -1.25/180 Daily Disposable Contact Lens with UV blocker
- Manufacturer
- CooperVision Inc.
- Category
- Medical Device — Contact Lenses
- Affected units
- 1,260
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: U0108940
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
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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