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

TECNIS Multifocal Foldable Acrylic Intraocular Lens, Model No — recall Z-2863-2016

U.S. FDA — Device Enforcement · United States · 2016-08-26 · Class II

As described by U.S. FDA — Device Enforcement: TECNIS Multifocal Foldable Acrylic Intraocular Lens, Model No. ZMA00 The product is indicated for primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by extracapsular cataract extraction and who desire n

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2863-2016
Date of alert
2016-08-26
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Abbott Medical Optics Inc. (AMO)
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Worldwide Distribution - US nationwide, PR, and Internationally to Canada, Latin America, Europe, Africa, Middle East, and Asia Pacific.
Barcode (EAN/GTIN)
8213991504
Reported risk: Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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