PlainRecalls
FDA Devices Moderate Class II Ongoing

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.

Reported: October 9, 2024 Initiated: August 29, 2024 #Z-3311-2024

Product Description

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.

Reason for Recall

Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience poor visual acuity

Details

Recalling Firm
CooperVision, Inc.
Units Affected
2443 lenses
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Location
West Henrietta, NY

Frequently Asked Questions

What product was recalled?
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.. Recalled by CooperVision, Inc.. Units affected: 2443 lenses.
Why was this product recalled?
Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience poor visual acuity
Which agency issued this recall?
This recall was issued by the FDA Devices on October 9, 2024. Severity: Moderate. Recall number: Z-3311-2024.