The Recall Desk
HighFDA (Devices)·Z-2151-2021·Announced 2021-08-04

CooperVision Contact Lenses Recalled for Misaligned Axis Mark

CooperVision is recalling MEDIFLEX ELITE 1 DAY TORIC daily disposable contact lenses (lot W0106167) due to misaligned axis marks that can cause blurred vision.

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 FDA Class II medical device recall qualifies as High severity under the rubric criterion for 'risk-of-harm products where injury has not yet been reported.' The misaligned axis mark poses a genuine risk of vision impairment, but no illnesses or injuries are documented in the source material.

Plain-English summary

CooperVision Inc. is recalling MEDIFLEX ELITE 1 DAY TORIC daily disposable contact lenses with UV blocker. The affected lot is W0106167, sold in packages of 90 lenses.

The contact lenses contain a manufacturing defect: the axis mark can be misaligned on the lens. When misaligned, the axis mark causes patients to experience blurred vision while wearing the lenses.

The recalled lenses were distributed worldwide. In the United States, distribution occurred in Florida, New York, Tennessee, Ohio, North Carolina, and Wisconsin. The product was also distributed internationally to France, the United Arab Emirates, Brazil, Australia, New Zealand, Taiwan, and Canada.

Patients using lenses from lot W0106167 should discontinue use immediately and contact their eye care provider. Eye care providers should work with CooperVision to arrange returns and replacement lenses.

The recalled product

Product
MEDIFLEX ELITE 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
  • axis-misalignment
  • vision-defect

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