Events

Recall of Device Recall LAUREATE World Phaco System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Alcon Research, Ltd..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    74825
  • Event Risk Class
    Class 2
  • Event Number
    Z-2834-2016
  • Event Initiated Date
    2016-07-28
  • Event Date Posted
    2016-09-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-06-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148531
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Unit, phacofragmentation - Product Code HQC
  • Reason
    Steps 16-25 are missing from the laureate multipak fms directions for use (dfu).
  • 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.

Device

Device Recall LAUREATE World Phaco System
  • Model / Serial
    Lot Numbers: 1658863H, 1805033H, 1805034H, 1817516H, 1817517H, 1826141H, 1826142H, 1857622H, 1857623H, 1868399H, 1868400H
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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 Description
    LAUREATE World Phaco System
  • Manufacturer
    Alcon Research, Ltd.

Manufacturer

Alcon Research, Ltd.
  • Manufacturer Address
    Alcon Research, Ltd., 6201 South Fwy, Fort Worth TX 76134-2099
  • Manufacturer Parent Company (2017)
    Novartis Ag
  • Source
    USFDA