CLASS II Device recall · Reported 21 Sep 2016 · FDA Enforcement Report

Laureate World Phaco System recalled by Alcon Research

Alcon Research is recalling Laureate World Phaco System. The recall was initiated on 28 Jul 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers: 1658863H, 1805033H, 1805034H, 1817516H, 1817517H, 1826141H, 1826142H, 1857622H, 1857623H, 1868399H, 1868400H

Quantity recalled8,646 UNITS

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2834-2016
FDA event ID: 74825
Recalling firm: Alcon Research, Fort Worth, TX
Classification: Class II
Status: Terminated
Recall initiated: 28 Jul 2016
FDA classified: 15 Sep 2016
Reported: 21 Sep 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

28 Jul 2016	Recall initiated by company
15 Sep 2016	Classified by FDA	+49 days
21 Sep 2016	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Steps 16-25 are missing from the LAUREATE Multipak FMS Directions for Use (DFU)

Product as listed by the FDA

LAUREATE World Phaco System

Where it was distributed

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.

Questions about this recall

Is Laureate World Phaco System recalled?

Yes. Alcon Research recalled Laureate World Phaco System on 28 Jul 2016. The recall is Class II and its status is Terminated. Recall number Z-2834-2016.

Why was it recalled?

Steps 16-25 are missing from the LAUREATE Multipak FMS Directions for Use (DFU)

Which lots are affected?

Lot Numbers: 1658863H, 1805033H, 1805034H, 1817516H, 1817517H, 1826141H, 1826142H, 1857622H, 1857623H, 1868399H, 1868400H

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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