Z-2856-2016Class II

TECNIS Multifocal 1-Piece Intraocular Lens, Model No. ZKB00, ZLB00; The product is indicated for primary...

Name: Z-2856-2016 TECNIS Multifocal 1-Piece Intraocular Lens, Model No. ZKB00, ZLB00; The product is indicated for primary...
Creator: Abbott Medical Optics Inc. (AMO)
Published: 2016-08-26
License: https://open.fda.gov/license/

Advanced Medical Optics, Inc. / initiated 2016-08-26 / Terminated / root cause: manufacturing process

FDA source

Abbott Medical Optics Inc. (AMO) began a recall of TECNIS Multifocal 1-Piece Intraocular Lens, Model No. ZKB00, ZLB00; The product is indicated for primary implantation for the visual correction of aphakia in... on 2016-08-26. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2856-2016
Classification: Class II
Status: Terminated
Initiated: 2016-08-26
Posted: 2016-09-21
Terminated: 2016-12-23
Recalling firm: Advanced Medical Optics, Inc.
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
Product code: HQL Intraocular Lens
Reason for recall: 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 tag: manufacturing process
FDA 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 [email protected]. 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 in commerce: 77 units
Distribution: Worldwide Distribution - US nationwide, PR, and Internationally to Canada, Latin America, Europe, Africa, Middle East, and Asia Pacific.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2856-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2855-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-28	2016-09-21
Z-2856-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-28	2016-09-21
Z-2857-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-28	2016-09-21
Z-2858-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-28	2016-09-21
Z-2859-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-28	2016-09-21
Z-2860-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-28	2016-09-21
Z-2861-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-28	2016-09-21
Z-2862-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-28	2016-09-21
Z-2863-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-28	2016-09-21
Z-2864-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-28	2016-09-21

Product code HQL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)