The Recall Desk
HighFDA (Devices)·Z-2149-2021·Announced 2021-08-04

CLARITI 1 DAY TORIC Contact Lenses Recalled Due to Axis Mark Misalignment

CooperVision is recalling CLARITI 1 DAY TORIC contact lenses (Lot W0106167) due to misaligned axis marks that can cause blurred vision. Affected patients should discontinue use and contact their eye care provider.

What this means for you

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 involving a medical device with a manufacturing defect that directly causes vision impairment. Although no illnesses or injuries have been reported, the defect creates a genuine risk of harm to patient safety, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

CooperVision Inc. is recalling CLARITI 1 DAY TORIC Daily Disposable Contact Lenses with UV blocker due to a manufacturing defect. Misaligned placement of the axis mark—which indicates proper lens orientation for astigmatism correction—can cause patients to experience blurred vision.

The recall affects Lot Number W0106167, distributed in the United States (Florida, New York, Tennessee, Ohio, North Carolina, and Wisconsin) and internationally (France, United Arab Emirates, Brazil, Australia, New Zealand, Taiwan, and Canada).

Patients using lenses from this lot should discontinue use and contact their eye care provider for replacement lenses or alternatives. No illnesses or injuries have been reported to date.

The recalled product

Product
CLARITI 1 DAY TORIC -DIAGNOSTIC Power-07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker
Manufacturer
CooperVision Inc.
Category
Medical Device — Contact Lens / Vision Correction
Hazard
  • axis-misalignment
  • blurred-vision

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

Distributed nationwide across the United States.

Related recalls

Same category