The Recall Desk
HighFDA (Devices)·Z-2146-2021·Announced 2021-08-04

CooperVision CLARITI 1 DAY TORIC contact lenses recalled for axis mark misalignment

CooperVision is recalling CLARITI 1 DAY TORIC daily disposable contact lenses due to misaligned axis marks that can cause blurred vision. Affected lenses in lot U0108833 were distributed in seven US states and internationally.

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 involving a manufacturing defect that creates risk of visual impairment. No illnesses or serious injuries have been reported. The hazard is theoretical (blurred vision has not been documented to occur), which under the rubric places this at High rather than Severe.

Plain-English summary

CooperVision Inc. is recalling CLARITI 1 DAY TORIC daily disposable contact lenses with UV blocker in the specific prescription of Power -07.00 -1.75/170. The recall affects Lot Number U0108833, consisting of 90 lenses.

The misalignment of the axis mark on affected lenses can cause patients to experience blurred vision. This manufacturing defect requires identification and replacement of affected product.

The affected lenses were distributed worldwide. In the United States, distribution occurred in Florida, New York, Tennessee, Ohio, North Carolina, and Wisconsin. Internationally, distribution included France, the United Arab Emirates, Brazil, Australia, New Zealand, Taiwan, and Canada.

Patients currently wearing affected lenses should contact their eye care provider. If you have lenses from this lot, discontinue use and consult your eye care professional about replacement or alternative options.

The recalled product

Product
CLARITI 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker
Manufacturer
CooperVision Inc.
Category
Medical Device — Vision / 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: U0108833

Distribution

Distributed nationwide across the United States.

Related recalls

Same category