The Recall Desk
HighFDA (Devices)·Z-2150-2021·Announced 2021-08-04

Contact lens recall: misaligned axis mark may cause blurred vision

CooperVision is recalling CLARITI 1 DAY TORIC contact lenses (Lot W0106167) due to misaligned axis marks that may cause blurred vision. The recall affects 450 lenses distributed across select U.S. states and multiple countries.

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 of a medical device with a theoretical risk of blurred vision. No illnesses, injuries, or hospitalizations have been reported. Per the severity rubric, recalls involving risk-of-harm products where injury has not yet been reported score as High (3).

Plain-English summary

CooperVision Inc. is recalling CLARITI 1 DAY TORIC daily disposable contact lenses with UV blocker (Lot Number W0106167). Misaligned placement of the axis mark on these lenses can cause patients to experience blurred vision.

The recall affects 450 lenses distributed worldwide, including to the U.S. states of Florida, New York, Tennessee, Ohio, North Carolina, and Wisconsin, as well as to France, the United Arab Emirates, Brazil, Australia, New Zealand, Taiwan, and Canada.

The axis alignment is critical for proper vision correction in toric lenses, which are designed to correct astigmatism. Misalignment can result in improper optical performance and blurred or distorted vision for patients wearing the affected lenses.

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 — 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: W0106167

Distribution

Distributed nationwide across the United States.

Related recalls

Same category