Z-2858-2016Class II

TECNIS 1-Piece IOL, Model No. ZCB00 The product is indicated for implantation for the visual correction of...

Name: Z-2858-2016 TECNIS 1-Piece IOL, Model No. ZCB00 The product is indicated for implantation for the visual correction of...
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 1-Piece IOL, Model No. ZCB00 The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens... 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-2858-2016
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 1-Piece IOL, Model No. ZCB00 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: 65 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. 2005271506 5914601206 4651021512 5807371506 4427981206 4427991206 4428001206 4428011206 4428021206 4428031206 4428041206 4428051206 4428061206 4428071206 4428081206 4428091206 4428101206 4428111206 4428121206 4428131206 4428141206 4428151206 4428161206 4428171206 4428181206 4428191206 4428201206 4428211206 4428221206 4428231206 4428241206 4428251206 4428261206 4428271206 4428281206 4428291206 4428311206 4428321206 4428331206 4428341206 4428351206 4428361206 4428371206 4428381206 5152461501 5152471501 5152481501 5152491501 5152501501 5152531501 5152541501 5152551501 5152561501 5152571501 5152581501 5152591501 5152601501 5152611501 5152621501 5152631501 5152641501 5152651501 5152661501 5152671501 4428301206

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2858-2016
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)