Contact lens recall: misaligned axis mark may cause blurred vision
CooperVision is recalling CLARITI 1 DAY TORIC contact lenses (Lot W0106167) due to misaligned axis marks that may cause blurred vision. The recall affects 450 lenses distributed across select U.S. states and multiple countries.
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 of a medical device with a theoretical risk of blurred vision. No illnesses, injuries, or hospitalizations have been reported. Per the severity rubric, recalls involving risk-of-harm products where injury has not yet been reported score as High (3).
Plain-English summary
CooperVision Inc. is recalling CLARITI 1 DAY TORIC daily disposable contact lenses with UV blocker (Lot Number W0106167). Misaligned placement of the axis mark on these lenses can cause patients to experience blurred vision.
The recall affects 450 lenses distributed worldwide, including to the U.S. states of Florida, New York, Tennessee, Ohio, North Carolina, and Wisconsin, as well as to France, the United Arab Emirates, Brazil, Australia, New Zealand, Taiwan, and Canada.
The axis alignment is critical for proper vision correction in toric lenses, which are designed to correct astigmatism. Misalignment can result in improper optical performance and blurred or distorted vision for patients wearing the affected lenses.
The recalled product
- Product
- CLARITI 1 DAY TORIC Power -07.00 -1.75/170 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: 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
Same manufacturer · CooperVision Inc.
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Same hazard · blurred vision
See all →- HighAlcon contact lenses recalled for manufacturing quality defect
FDA (Devices) · 2024-10-09
- 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
- HighCooperVision CLARITI 1 DAY TORIC contact lenses recalled for axis mark misalignment
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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