Abbott Medical Optics Inc. (AMO): TECNIS Multifocal 1-Piece Intraocular Lens, Model No. ZKB00, ZLB00; 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 near, intermediate, and distance vision with increased spectacle independence. The lens is intended to be placed in the capsular bag

Recall number

Z-2856-2016

Recalling firm

Abbott Medical Optics Inc. (AMO)

Product

TECNIS Multifocal 1-Piece Intraocular Lens, Model No. ZKB00, ZLB00; 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 near, intermediate, and distance vision with increased spectacle independence. The lens is intended to be placed in the capsular bag

Status

Terminated

Initiated

2016-08-26

Posted

2016-09-21

Terminated

2016-12-23

Reason

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.

Root cause

Process control

Action

Abbott Medical Optics, Inc. sent an Urgent Field Safety Notice to all affected customers to inform them that Abbott Medical Optics (AMO) is recalling 737 IOLs due to detection of an inspection equipment malfunction that resulted in a total of 737 distributed lenses not being fully checked prior to release. The letter informs customers that this malfunction may result in the release of mislabeled IOLs. The letter informs the customers of the actions to be taken. Customers are instructed to complete Customer Reply Form and fax it to AMO Quality Assurance at 714-247-4510 or email to RegCompliOne@abbott.com. Customers with any questions related to the IOL return process are instructed to contact an AMO Customer Service Representative at 877-266-4543. Customers with product complaints or adverse events are instructed to inform AMO by calling 877-266-4543.

Quantity

77 units

Distribution

Worldwide Distribution - US nationwide, PR, and Internationally to Canada, Latin America, Europe, Africa, Middle East, and Asia Pacific.

Lot, serial or model codes

ZKB00 Serial No. 8667461602  8667751602 8667471602  8667761602 8667481602  8667771602 8667491602  8667781602 8667501602  8667801602 8667511602  8667811602 8667521602  8667821602 8667531602  8667831602 8667541602  8667841602 8667551602  8667851602 8667561602  8667861602 8667571602  8667871602 8667581602  8667881602 8667591602  8667891602 8667601602  8667901602 8667611602  8667911602 8667621602  8667921602 8667631602  8667931602 8667641602  8667961602 8667661602  8667971602 8667671602  8667981602 8667681602  8667991602 8667691602  8668001602 8667701602  8668011602    ZLB00 Serial No. 8960421506 8960431506 8960441506 8960451506 8960461506 8960471506 8960481506 8960501506 8960511506 8960531506 8960541506 8960581506 8960591506 8960621506 8960631506 8960641506 8960651506 8960661506 8960671506 8960681506 8960691506 8960701506 8960711506 8960721506 8960731506 8960741506

510(k) numbers

not on file

PMA numbers

["P980040"]

Product code

HQL

Firm FEI

3003843509

Firm city

Santa Ana

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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