Contact Lens Axis Mark Misalignment Causes Blurred Vision
CooperVision's FRESH DAY 1 DAY TORIC contact lenses (lot W0106186) are recalled because misaligned axis marks can cause blurred vision. Affected lenses were distributed worldwide, including in the US, France, Brazil, and other 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This FDA Class II recall involves a manufacturing defect that impairs product function (axis misalignment causing blurred vision), but no injuries or hospitalizations have been reported. The hazard is functional impairment rather than a direct safety threat.
Plain-English summary
CooperVision Inc. is recalling FRESH DAY 1 DAY TORIC daily disposable contact lenses with UV blocker due to a manufacturing defect. The axis mark on affected lenses can be misaligned, which may cause patients to experience blurred vision.
The affected lot (W0106186) was distributed worldwide, with US distribution in Florida, New York, Tennessee, Ohio, North Carolina, and Wisconsin. International distribution included France, United Arab Emirates, Brazil, Australia, New Zealand, Taiwan, and Canada.
Patients currently using lenses from the affected lot should discontinue use and contact their eye care provider for replacement lenses.
The recalled product
- Product
- FRESH DAY 1 DAY TORIC Power -07.00 -1.25/010 Daily Disposable Contact Lens with UV blocker
- Manufacturer
- CooperVision Inc.
- Category
- Medical Device — Contact Lenses
- Affected units
- 180
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: W0106186
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 · blurred vision
See all →- HighAlcon contact lenses recalled for manufacturing quality defect
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- HighContact Lens Axis Mark Misalignment May Cause Blurred Vision
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