FDA-Device2024-10-09Class II
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.
CooperVision, Inc.
Hazard
Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience poor visual acuity
Sold states
Worldwide distribution - US Nationwide and the country of Canada.
Affected count
2443 lenses
Manufactured in
180 Thruway Park Dr, N/A, West Henrietta, NY, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3311-2024Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief