Events

Recall of CATALYS PRECISION LASER SYSTEM - MAIN UNIT

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

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
    17515
  • Event Risk Class
    II
  • Event Initiated Date
    2015-03-12
  • 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
    Amo quality assurance was notified of a complaint that a patient's left eye was treated with a right eye template. the left eye cataract incisions template was selected as a starting basis for patient treatment planning. from there the right eye/ left eye cataract incisions template buttons were toggled which caused right eye cataract incisions template numbers to be auto populated into the left eye template. this is a software anomaly which translates into a potential incorrect treatment at an occurrence rate higher than established in the risk management file.

Device

CATALYS PRECISION LASER SYSTEM - MAIN UNIT
  • Model / Serial
    Model Catalog: CATALYS SYSTEM-I (Lot serial: SOFTWARE VERSION 3.00.05)
  • Product Description
    CATALYS PRECISION LASER SYSTEM - MAIN UNIT
  • Manufacturer
    AMO CANADA COMPANY

Manufacturer

AMO CANADA COMPANY