Contact lenses with misaligned axis may cause poor visual acuity
CooperVision is recalling Biofinity Toric Multifocal soft contact lenses manufactured with misaligned axes resulting in incorrect optical power. Affected lenses may cause poor visual acuity.
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: FDA Class II medical device recall with no reported hospitalizations, injuries, or illnesses. The hazard qualifies as a risk-of-harm product (optical defect potentially affecting vision) where injury has not yet been reported, meeting the rubric criterion for Score 3 (High).
Plain-English summary
CooperVision, Inc. is recalling Biofinity Toric Multifocal soft contact lenses due to a manufacturing defect. The lenses were manufactured with a misaligned axis, resulting in incorrect optical power that may cause poor visual acuity in affected wearers.
The recall affects lenses distributed in the United States and Canada. The specific lot numbers affected are identified in the FDA recall notice.
Consumers who have used lenses from the affected lot numbers should contact CooperVision or their eye care professional regarding the recall.
The recalled product
- Product
- Biofinity Toric Multifocal 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.
- Affected units
- 2,443
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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