Events

Recall of CENTURION VISION SYSTEM - ACTIVE IRRIGATION FMS PACK INFUSION SLEEVES

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
    52075
  • Event Risk Class
    II
  • Event Initiated Date
    2016-05-04
  • 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
    Alcon canada is conducting this voluntary medical device removal for specific lots of centurion fms packs due to the possible presence of a molding irregularity found within the aspiration leur which may result in a reduction of vacuum within the aspiration line.

Device

CENTURION VISION SYSTEM - ACTIVE IRRIGATION FMS PACK INFUSION SLEEVES
  • Model / Serial
    Model Catalog: 8065752918 (Lot serial: 1802311H); Model Catalog: 8065752917 (Lot serial: 1802311H); Model Catalog: 8065752201 (Lot serial: 1804698H); Model Catalog: 8065752200 (Lot serial: 1804698H); Model Catalog: 8065752201 (Lot serial: 1804697H); Model Catalog: 8065752200 (Lot serial: 1804697H); Model Catalog: 8065752201 (Lot serial: 1804696H); Model Catalog: 8065752200 (Lot serial: 1804696H); Model Catalog: 8065752201 (Lot serial: 1804691H); Model Catalog: 8065752200 (Lot serial: 1804691H); Model Catalog: 8065752201 (Lot serial: 1794168H); Model Catalog: 8065752200 (Lot serial: 1804849H); Model Catalog: 8065752201 (Lot serial: 1794164H); Model Catalog: 8065752200 (Lot serial: 1794164H); Model Catalog: 8065752201 (Lot serial: 1794163H); Model Catalog: 8065752200 (Lot serial: 1794163H); Model Catalog: 8065752201 (Lot serial: 1794161H); Model Catalog: 8065752200 (Lot serial: 1794161H); Model Catalog: 8065752201 (Lot serial: 1794159H); Model Catalog: 8065752200 (Lot serial: 1794159H); Model Catalog: 80657522
  • Product Description
    CENTURION VISION SYSTEM - ACTIVE IRRIGATION FMS PACK INFUSION SLEEVES;CENTURION VISION SYSTEM - ACTIVE IRRIGATION FMS PACK W/INTREPID ULTRA SLEEVES;CENTURION VISION SYSTEM - ACTIVE IRRIGATION FMS PACK BASIC
  • Manufacturer
    ALCON CANADA INC.

Manufacturer

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