The Recall Desk
HighFDA (Devices)·Z-2148-2021·Announced 2021-08-04

Contact Lens Recall: Misaligned Axis Mark May Cause Blurred Vision

CooperVision is recalling SPECSAVERS UMERE TORIC daily disposable contact lenses with UV blocker due to a manufacturing defect in which misaligned axis marks may 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: FDA Class II recall with no reported illnesses or injuries. The hazard is theoretical—misaligned axis marks that may cause blurred vision—placing this within the rubric category of risk-of-harm products where injury has not yet been reported.

Plain-English summary

CooperVision Inc. is recalling SPECSAVERS UMERE TORIC Power -07.00 -1.25/180 Daily Disposable Contact Lenses with UV blocker. The affected lenses are identified by lot number U0108940 and come in packages of 60 lenses.

The lenses have a manufacturing defect: the axis mark may be misaligned. When worn, this misalignment can cause patients to experience blurred vision.

The affected lenses were distributed internationally and within the United States in Florida, New York, Tennessee, Ohio, North Carolina, and Wisconsin.

Patients who have purchased or are using these contact lenses should stop wearing them and contact their eye care provider or CooperVision for information about replacement or return options.

The recalled product

Product
SPECSAVERS UMERE 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