The Recall Desk
HighFDA (Devices)·Z-2145-2021·Announced 2021-08-04

Contact lens recall due to misaligned axis marking

CooperVision Inc. is recalling FRESH DAY 1 DAY TORIC contact lenses (Lot R0121629) due to misaligned axis marks that may cause blurred vision in wearers.

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 a risk-of-harm product where the defect can cause blurred vision, potentially affecting patient safety. Although no illnesses or injuries have been reported, the misaligned axis mark poses a direct risk to vision correction and patient well-being.

Plain-English summary

CooperVision Inc. is recalling FRESH DAY 1 DAY TORIC Power -07.50 -0.75/060 daily disposable contact lenses with UV blocker. The recalled lenses are identified by lot number R0121629.

The recall is due to misalignment of the axis mark on the lenses. This misalignment can cause patients to experience blurred vision when wearing the affected lenses.

The affected lenses were distributed worldwide, including across the United States in Florida, New York, Tennessee, Ohio, North Carolina, and Wisconsin, as well as in France, United Arab Emirates, Brazil, Australia, New Zealand, Taiwan, and Canada. The product comes in a 90-lens package.

Patients who have contact lenses from the recalled lot should stop using them immediately and contact their eye care provider for a replacement or alternative product. Those who experience vision problems while wearing these lenses should seek medical attention.

The recalled product

Product
FRESH DAY 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
  • 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: R0121629

Distribution

Distributed nationwide across the United States.

Related recalls

Same category