FDA recall Z-3310-2024

CooperVision, Inc. · Class II · device

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.

Reason for recall

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

Distribution

Worldwide distribution - US Nationwide and the country of Canada.

Key facts

Status
Ongoing
Initiation date
2024-08-29
Report date
2024-10-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
West Henrietta, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3310-2024