Events

Recall of CRYOMATIC SYSTEM - RETINAL PROBE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by INNOVA MEDICAL OPHTHALMICS 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
    28778
  • Event Risk Class
    III
  • Event Initiated Date
    2011-10-27
  • 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
    Keeler ltd has recently updated the cryomatic probe user instruction kcu 402 from issue 1 to issue 2 regarding the sterilization methods to be used. a technical bulletin had been supplied to all users describing the changes. it has now been discovered that issue 1 of the instruction has been supplied with probes distributed between the 1st of september 2010 and the 26th of april 2011.

Device

CRYOMATIC SYSTEM - RETINAL PROBE
  • Model / Serial
    Model Catalog: 2509-P-8002 (Lot serial: ); Model Catalog: 2509-P-8003 (Lot serial: ); Model Catalog: 2509-P-8004 (Lot serial: ); Model Catalog: 2509-P-8006 (Lot serial: ); Model Catalog: 2509-P-8001 (Lot serial: ); Model Catalog: 2509-P-8000 (Lot serial: )
  • Product Description
    CRYOMATIC SYSTEM - RETINAL PROBE
  • Manufacturer
    INNOVA MEDICAL OPHTHALMICS INC.

Manufacturer

INNOVA MEDICAL OPHTHALMICS INC.