Z-2863-2016Class II

TECNIS Multifocal Foldable Acrylic Intraocular Lens, Model No. ZMA00 The product is indicated for primary...

Name: Z-2863-2016 TECNIS Multifocal Foldable Acrylic Intraocular Lens, Model No. ZMA00 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 Foldable Acrylic Intraocular Lens, Model No. ZMA00 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-2863-2016
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 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 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: 41 units
Distribution: Worldwide Distribution - US nationwide, PR, and Internationally to Canada, Latin America, Europe, Africa, Middle East, and Asia Pacific.
Product codes and lots: Serial No. 8213991504 8214001504 8214011504 8214021504 8214031504 8214041504 8214051504 8214061504 8214071504 8214101504 8538801603 8538821603 8538831603 8538841603 8538871603 8538891603 8538901603 8538971603 8538981603 8416821507 8416831507 8416841507 8416851507 8416911507 8416921507 8416951507 8416961507 8416971507 8416991507 8417001507 8417011507 8417021507 8417041507 8417071507 8417081507 8417091507 8417101507 8445191507 8505901605 8505911605 8505961605

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2863-2016
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)