The Recall Desk
HighFDA (Devices)·Z-2147-2021·Announced 2021-08-04

CooperVision CLARITI Contact Lenses Recalled for Misaligned Axis Marks

CooperVision is recalling CLARITI 1 DAY TORIC contact lenses (Lot U0108940) because misaligned axis marks can cause blurred vision in patients.

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 device recall for a manufacturing defect that poses a risk to patient vision. Misaligned axis marks can cause blurred vision in toric lens wearers. No injuries or illnesses have been reported, placing this in the "risk-of-harm products where injury has not yet been reported" criterion.

Plain-English summary

CooperVision Inc. is recalling CLARITI 1 DAY TORIC daily disposable contact lenses with UV blocker due to a manufacturing defect.

Specifically, misaligned placement of the axis mark on the lens can cause patients to experience blurred vision. The recalled lot is U0108940, which includes 1260 lenses.

The affected lenses were distributed worldwide and in the United States across Florida, New York, Tennessee, Ohio, North Carolina, and Wisconsin, as well as internationally in France, United Arab Emirates, Brazil, Australia, New Zealand, Taiwan, and Canada.

Patients who use these lenses should discontinue use and contact their eye care provider. CooperVision and health care providers have been notified of this recall.

The recalled product

Product
CLARITI 1 DAY TORIC Power -07.00 -1.25/180 Daily Disposable Contact Lens with UV blocker
Manufacturer
CooperVision Inc.
Category
Medical Device — Contact Lenses
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: U0108940

Distribution

Distributed nationwide across the United States.

Related recalls

Same category