Events

Retiro De Equipo (Recall) 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

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por iNova Pharmaceuticals Australia Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2016-RN-01467-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-11-16
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01467-1
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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.
  • Acción
    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...
  • Modelo / 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