Z-2064-2017Class II

Healon Duet, Part No. 10290080, 10220010, 10220011 and 10220012

Name: Z-2064-2017 Healon Duet, Part No. 10290080, 10220010, 10220011 and 10220012
Creator: Abbott Medical Optics Inc. (AMO)
Published: 2017-04-01
License: https://open.fda.gov/license/

Advanced Medical Optics, Inc. / initiated 2017-04-01 / Terminated / root cause: manufacturing process

FDA source

Abbott Medical Optics Inc. (AMO) began a recall of Healon Duet, Part No. 10290080, 10220010, 10220011 and 10220012 on 2017-04-01. FDA classified it as Class II and gives the reason as "Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process". 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-2064-2017
Classification: Class II
Status: Terminated
Initiated: 2017-04-01
Posted: 2017-05-10
Terminated: 2017-11-27
Recalling firm: Advanced Medical Optics, Inc.
Product: Healon Duet, Part No. 10290080, 10220010, 10220011 and 10220012
Product code: LZP Aid, Surgical, Viscoelastic
Reason for recall: Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: A recall letter was sent to customers on 4/1/17 to inform them that AMO has voluntarily initiated this Action because a remote possibility exists that certain Healon OVD solutions in the affected lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process. Use of OVD solutions with glass particles could potentially lead to intraocular injury. Customers are instructed to complete the Customer Reply Form and fax it to AMO Quality Assurance at 714-247-4510 or email to [email protected] within 3 business days of receipt of the letter. Customers with product complaints or adverse events are instructed to inform AMO by calling 877-266-4543. Customers that do report a complaint are instructed to provide the Healon OVD lot number and, if a patient was involved, the date of surgery, a description of the event and patient outcome.
Quantity in commerce: 293,867 units total
Distribution: US and worldwide: Austria Belgium Croatia Czech Republic Denmark Finland France Germany Great Britain Iceland Ireland Israel Italy Latvia Lebanon Lithuania Netherlands Norway Portugal Spain Sweden Switzerland Tunisia Turkey Russian Fed Guadeloupe Sri Lanka Australia China Hong Kong Indonesia Malaysia Singapore South Korea Taiwan Thailand Japan Chile Colombia Costa Rica Ecuador
Product codes and lots: UB32636

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2064-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2062-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-17	2017-05-10
Z-2063-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-17	2017-05-10
Z-2064-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-17	2017-05-10
Z-2065-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-17	2017-05-10
Z-2066-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-17	2017-05-10
Z-2067-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-17	2017-05-10

Product code LZP

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)