Events

Recall of MEASURING PRISMS

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
    17576
  • Event Risk Class
    III
  • Event Initiated Date
    2009-10-13
  • 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
    In europe hagg-streit received 3 reports concerning leaking tonometer prisms. a known reason of failing tonometer prisms is the use of disinfectants not approved and not released by haag-streit maily cool wipes. this might lead to irritation of cornea and in rare cases to reversible corneal erosions.

Device

MEASURING PRISMS
  • Model / Serial
    Model Catalog: 1000855 (Lot serial: >100 CONTACT MFG)
  • Product Description
    GOLDMANN APPLANATION TONOMETER PRISM
  • Manufacturer
    INNOVA MEDICAL OPHTHALMICS INC.

Manufacturer

INNOVA MEDICAL OPHTHALMICS INC.