Events

Recall of OCTOPUS 101 PERIMETER

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
    17479
  • Event Risk Class
    III
  • Event Initiated Date
    2012-11-26
  • 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
    Haag-streit received information from four customers regarding a possible deviation in the stimulus luminance of the perimeter octopus 101. one of these devices showed deviations between 1.5db and 2.2db from the tolerance limit and between 2.5db and 3.2db from the specified value respectively (en is012866). long term performance study of the stimulus luminance conducted by haag-streit on the market showed devices deviations from the tolerance limit. the largest of these deviations was l.Odb from the threshold and 2.0db from the specified value respectively. we consider the deviation between 2.5db and 3.2db from the specified value mentioned above as worst case.

Device

OCTOPUS 101 PERIMETER
  • Model / Serial
    Model Catalog: 0101 (Lot serial: 469); Model Catalog: 0101 (Lot serial: 1296); Model Catalog: 0101 (Lot serial: 753); Model Catalog: 0101 (Lot serial: 511); Model Catalog: 0101 (Lot serial: 171); Model Catalog: 0101 (Lot serial: 434); Model Catalog: 0101 (Lot serial: 425); Model Catalog: 0101 (Lot serial: 402); Model Catalog: 0101 (Lot serial: 391)
  • Product Description
    Haag-Streit Perimeter Octopus 101
  • Manufacturer
    INNOVA MEDICAL OPHTHALMICS INC.

Manufacturer

INNOVA MEDICAL OPHTHALMICS INC.