The Recall Desk
HighFDA (Devices)·Z-2143-2021·Announced 2021-08-04

Contact Lens Recall: Misaligned Axis Mark May Cause Blurred Vision

CooperVision is recalling CLARITI 1 DAY TORIC contact lenses with misaligned axis marks that may cause blurred vision. The defective lenses were distributed worldwide including multiple U.S. states.

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: FDA Class II medical device recall where the defect directly impacts the product's intended use by causing blurred vision. This qualifies as a risk-of-harm product where no illnesses or injuries have been reported.

Plain-English summary

CooperVision Inc. is recalling CLARITI 1 DAY TORIC daily disposable contact lenses with Power -07.50, cylinder -0.75, and axis 060 due to a manufacturing defect.

A misaligned placement of the axis mark on affected lenses can cause patients to experience blurred vision. The axis mark alignment is critical to providing correct vision correction.

The affected product (lot number R0121629, 90-lens packages) was distributed worldwide, including in the United States in Florida, New York, Tennessee, Ohio, North Carolina, and Wisconsin, as well as internationally in France, the United Arab Emirates, Brazil, Australia, New Zealand, Taiwan, and Canada.

Patients who have received affected lenses should contact their eye care provider regarding this recall.

The recalled product

Product
CLARITI 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposable Contact Lens with UV blocker
Manufacturer
CooperVision Inc.
Category
Medical Device — Contact Lenses
Hazard
  • vision-defect
  • 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: R0121629

Distribution

Distributed nationwide across the United States.

Related recalls

Same category