Events

Recall of CONSTELLATION PNEUMATIC HANDPIECE DSP

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
    25455
  • Event Risk Class
    II
  • Event Initiated Date
    2013-04-16
  • 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 received complaints for the constellation pneumatic handpiece dsp product number 725.01 related to the tip dislodging from the hand piece during the surgical procedure. if the tip becomes dislodged from the hand piece while in the eye a patient injury may occur. the constellation pneumatic handpiece and tips are unlikely to cause injury when tips are attached in accord with the directions for use. however review of the complaint cases to date indicates potential for isolated instances of detachment to occur if the tip has not been correctly attached. therefore alcon has decided to halt manufacturing of this product and remove any remaining lots from the market.

Device

CONSTELLATION PNEUMATIC HANDPIECE DSP
  • Model / Serial
    Model Catalog: 725.01 (Lot serial: F85110); Model Catalog: 725.01 (Lot serial: F85466)
  • Product Description
    CONSTELLATION PNEUMATIC HANDPIECE DSP
  • Manufacturer
    ALCON CANADA INC.

Manufacturer

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