The Recall Desk
ModerateFDA (Devices)·Z-2153-2021·Announced 2021-08-04

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.

What this means for you

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
Hazard
  • blurred-vision
  • axis-misalignment

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

Distributed nationwide across the United States.

Related recalls

Same category