Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

LAUREATE World Phaco System Recalled by Alcon Research, Ltd. Due to Steps 16-25 are missing from the LAUREATE Multipak...

Date: July 28, 2016
Company: Alcon Research, Ltd.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Alcon Research, Ltd. directly.

Affected Products

LAUREATE World Phaco System

Quantity: 8,646 UNITS

Why Was This Recalled?

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

Where Was This Sold?

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.

About Alcon Research, Ltd.

Alcon Research, Ltd. has 26 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report