CooperVision CLARITI 1 DAY TORIC contact lenses recalled for axis mark misalignment
CooperVision is recalling CLARITI 1 DAY TORIC daily disposable contact lenses due to misaligned axis marks that can cause blurred vision. Affected lenses in lot U0108833 were distributed in seven US states and internationally.
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 involving a manufacturing defect that creates risk of visual impairment. No illnesses or serious injuries have been reported. The hazard is theoretical (blurred vision has not been documented to occur), which under the rubric places this at High rather than Severe.
Plain-English summary
CooperVision Inc. is recalling CLARITI 1 DAY TORIC daily disposable contact lenses with UV blocker in the specific prescription of Power -07.00 -1.75/170. The recall affects Lot Number U0108833, consisting of 90 lenses.
The misalignment of the axis mark on affected lenses can cause patients to experience blurred vision. This manufacturing defect requires identification and replacement of affected product.
The affected lenses were distributed worldwide. In the United States, distribution occurred in Florida, New York, Tennessee, Ohio, North Carolina, and Wisconsin. Internationally, distribution included France, the United Arab Emirates, Brazil, Australia, New Zealand, Taiwan, and Canada.
Patients currently wearing affected lenses should contact their eye care provider. If you have lenses from this lot, discontinue use and consult your eye care professional about replacement or alternative options.
The recalled product
- Product
- CLARITI 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker
- Manufacturer
- CooperVision Inc.
- 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: U0108833
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
- HighCLARITI 1 DAY TORIC Contact Lenses Recalled Due to Axis Mark Misalignment
FDA (Devices) · 2021-08-04
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