Alcon Research, Ltd.: Medical Device Recall in 2016 - (Recall #: Z-2834-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

LAUREATE World Phaco System

Product Classification:

Class II

Date Initiated: July 28, 2016

Date Posted: September 21, 2016

Recall Number: Z-2834-2016

Event ID: 74825

Reason for Recall:

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

Status: Terminated

Product Quantity: 8,646 UNITS

Code Information:

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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated