Events

Recall of EasySept HYDRO+ (3% hydrogen peroxide) Cleaning & Disinfecting Solution (Contact lens care kit) Affected Products :EasySept HYDRO + Duo Pack 480 mL EasySept HYDRO+ Value Pack 840 mL Easy Sept HYDRO + Starter Kit 120 mL

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by iNova Pharmaceuticals Australia Pty 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
    RC-2016-RN-01467-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-11-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01467-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    This recall has been initiated as a precautionary measure based on internal testing that simulated normal product use. there have been occasional occurrences where the residual peroxide remaining in the lens case after neutralisation was above product specification. this could lead to the user experiencing temporary ocular symptoms such as burning/stinging, irritation, and red eye.
  • Action
    Pharmacists and optometrists are advised to quarantine affected stock and to return them to the place of purchase for a credit. They are also advised that should a consumer return any stock affected by this issue; please offer them a full refund. Wholesalers are advised to immediately quarantine and destroy all affected/returned stock.

Device

EasySept HYDRO+ (3% hydrogen peroxide) Cleaning & Disinfecting Solution (Contact lens care kit) A...
  • Model / Serial
    EasySept HYDRO+ (3% hydrogen peroxide) Cleaning & Disinfecting Solution (Contact lens care kit)Affected Products :EasySept HYDRO + Duo Pack 480 mL EasySept HYDRO+ Value Pack 840 mL Easy Sept HYDRO + Starter Kit 120 mL All Batches ARTG Number: 203455
  • Manufacturer
    iNova Pharmaceuticals Australia Pty Ltd

Manufacturer

iNova Pharmaceuticals Australia Pty Ltd