Events

Recall of OCTOPUS 900 PRO

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
    51949
  • Event Risk Class
    II
  • Event Initiated Date
    2011-11-08
  • 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
    Due to a software error the background illumination of the cupola may not be switched on at the start of an examination. results will appear to be "better" than the actual ones. due to the software error an examination taken with the dynamic or normal strategy may show a huge overshoot in the cumulated defect (bebie) curve and the corresponding visual field indices (md and ms). the effect is less obvious with the top strategy. if these results are considered in isolation from the results of previous visual field examinations or from other examinations (e.G. intraocular pressure measurements or examinations of the optic nerve head) the visual field of the patient may remain untreated.

Device

OCTOPUS 900 PRO
  • Model / Serial
    Model Catalog: 7220002 (Lot serial: VARIOUS LOTS); Model Catalog: 7220001 (Lot serial: VARIOUS LOTS)
  • Product Description
    OCTOPUS 900 PRO
  • Manufacturer
    INNOVA MEDICAL OPHTHALMICS INC.

Manufacturer

INNOVA MEDICAL OPHTHALMICS INC.