Product Wiki · Recalls · U.S. FDA — Device Enforcement

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. — recall Z-3311-2024

U.S. FDA — Device Enforcement · United States · 2024-08-29 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-3311-2024
Date of alert
2024-08-29
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
CooperVision, Inc.
Product category
device
Product type
Devices
Reported risk: Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience poor visual acuity
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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