BIOFINITY XR TORIC Contact Lenses Recalled for Misaligned Axis Defect
CooperVision is recalling 607 BIOFINITY XR TORIC soft contact lenses due to a manufacturing defect with misaligned axis, resulting in incorrect power and poor visual acuity. The lenses were distributed in the US and Canada.
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 medical device recall involving a confirmed manufacturing defect (misaligned axis) that causes functional failure (incorrect lens power and poor visual acuity). Contact lenses are risk-of-harm medical devices, and while no illnesses or injuries have been reported, the defect poses a risk of vision-related complications.
Plain-English summary
BIOFINITY XR TORIC soft contact lenses manufactured by CooperVision, Inc. are being recalled. These lenses are indicated for correcting myopia or hyperopia with astigmatism in persons with presbyopia.
The recall is due to a manufacturing defect in which the lenses were produced with a misaligned axis, resulting in incorrect power and potentially causing poor visual acuity.
A total of 607 lenses were distributed nationwide in the United States and in Canada. Consumers who possess lenses from the affected lot numbers should stop using them and contact their eye care provider for replacement lenses with the correct power.
The recalled product
- Product
- BIOFINITY XR TORIC Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) with presbyopia in aphakic and non-aphakic persons.
- Manufacturer
- CooperVision, Inc.
- Category
- Medical Device — Contact Lenses
- Affected units
- 607
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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 2 products in this recall →Related recalls
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