Agency classClass IIOur severity:High FDA (Devices)·Z-2154-2021·Announced 2021-08-04

Daily Toric Contact Lenses Recalled for Misaligned Axis Mark

CooperVision is recalling SOFMED BREATHABLES 1 DAY TORIC contact lenses (Lot W0106167) due to misaligned axis marks that can cause blurred vision. Affected lenses were distributed in the US and internationally.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 involving a risk-of-harm product (blurred vision from manufacturing defect) with no reported injuries. Per the severity rubric, recalls involving risk-of-harm products where injury has not yet been reported receive a High (3) rating.

Plain-English summary

CooperVision Inc. is recalling SOFMED BREATHABLES 1 DAY TORIC daily disposable contact lenses (Lot Number W0106167) due to a manufacturing defect involving misaligned placement of the axis mark.

The misaligned axis mark can cause patients to experience blurred vision. This defect affects the lens's ability to provide proper visual correction.

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

Patients who have received lenses from the affected lot should contact their eye care provider immediately. Do not use the affected lenses and contact CooperVision for replacement options or return instructions.

The recalled product

Product: SOFMED BREATHABLES 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
Affected units: 90

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.

The notice also names 6 states specifically:

Part of a larger recall action

This product is one of 12 recalled by CooperVision Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 12 products in this recall →

Same manufacturer · CooperVision Inc.

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Same hazard · blurred vision