Events

Recall of MEL 80 EXCIMER LASER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CARL ZEISS CANADA 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
    43290
  • Event Risk Class
    II
  • Event Initiated Date
    2003-10-02
  • 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
    Same comments field 14 screen 1.

Device

MEL 80 EXCIMER LASER
  • Model / Serial
    Model Catalog: 320817 0300 000 (Lot serial: version under 1.4); Model Catalog: 320817 0300 000 (Lot serial: POLO and OPASS software); Model Catalog: 320817 0300 000 (Lot serial: S/N 873110); Model Catalog: 320817 0301 114 (Lot serial: versions under 1.4); Model Catalog: 320817 0301 114 (Lot serial: POLO and OPASS software); Model Catalog: 320817 0301 114 (Lot serial: S/N 873112)
  • Product Description
    MEL 80
  • Manufacturer
    CARL ZEISS CANADA LTD.

Manufacturer

CARL ZEISS CANADA LTD.