Z-2864-2016Class II

AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model No. Z9002 The product is indicated for...

Name: Z-2864-2016 AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model No. Z9002 The product is indicated for...
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 AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model No. Z9002 The product is indicated for 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-2864-2016
Classification: Class II
Status: Terminated
Initiated: 2016-08-26
Posted: 2016-09-21
Terminated: 2016-12-23
Recalling firm: Advanced Medical Optics, Inc.
Product: AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model No. Z9002 The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. 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. 1104621505 1164491602 1164501602 1164511602 1164521602 1164541602 1164551602 1164561602 1164571602 1164581602 1164601602 1164611602 1164621602 1164641602 1164651602 1164711602 1074911602 1074921602 1074931602 1074941602 1074951602 1074961602 1074971602 1074981602 1074991602 1075001602 1075011602 1075021602 1075031602 1075041602 1075051602 1075061602 1075071602 1075081602 1075091602 1075101602 1075111602 1075131602 1075141602 1075151602 1075121602

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2864-2016
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)