Events

Rappel de 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

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par iNova Pharmaceuticals Australia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2016-RN-01467-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-11-16
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01467-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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...
  • Modèle / numéro de série
    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