Z-2834-2016Class II

LAUREATE World Phaco System

Name: Z-2834-2016 LAUREATE World Phaco System
Creator: Alcon Research, Ltd.
Published: 2016-07-28
License: https://open.fda.gov/license/

Alcon Laboratories / initiated 2016-07-28 / Terminated / root cause: labeling and UDI

FDA source

Alcon Research, Ltd. began a recall of LAUREATE World Phaco System on 2016-07-28. FDA classified it as Class II and gives the reason as "Steps 16-25 are missing from the LAUREATE Multipak FMS Directions for Use (DFU)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2834-2016
Classification: Class II
Status: Terminated
Initiated: 2016-07-28
Posted: 2016-09-15
Terminated: 2017-06-07
Recalling firm: Alcon Laboratories
Product: LAUREATE World Phaco System
Product code: HQC Unit, Phacofragmentation
Reason for recall: Steps 16-25 are missing from the LAUREATE Multipak FMS Directions for Use (DFU)
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: All remaining inventory of the identified affected products within Alcon DCs will be supplied corrected directions for use material prior to any further shipments.
Quantity in commerce: 8,646 UNITS
Distribution: Burundi, China, Iran, South Korea, Taiwan, Thailand, USA. *** The recalled product is not sold in the USA or its territories. However, donated units are in use by a reduced number of USA clients for Medical Missions outside the country.
Product codes and lots: Lot Numbers: 1658863H, 1805033H, 1805034H, 1817516H, 1817517H, 1826141H, 1826142H, 1857622H, 1857623H, 1868399H, 1868400H

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2834-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2834-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-21	2016-09-15

Product code HQC

K021566Class IIInfinitiAlcon Laboratories, Inc. / cleared 2002-07-02

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)