Events

Recall of MONARCH IOL DELIVERY SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ALCON CANADA INC..

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
    144919
  • Event Risk Class
    II
  • Event Initiated Date
    2008-07-08
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    A labelling error was reported with respect to packaging of the monarch ii iol delivery system cartridge. specifically 3 monarch ii 'c' cartridges were found in monarch ii 'b' labelled pouches and carton.

Device

MONARCH IOL DELIVERY SYSTEM
  • Model / Serial
    Model Catalog: 8065-9777-58 (Lot serial: 174244)
  • Product Description
    MONARCH II B CARTRIDGE
  • Manufacturer
    ALCON CANADA INC.

Manufacturer

ALCON CANADA INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Novartis Ag
  • Source
    HC