Events

Retiro De Equipo (Recall) de Easyvision Umere Daily Contact Lenses (-6.50)30 x lenses for daily wear

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Specsavers 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-2015-RN-00303-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-04-10
  • 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-2015-RN-00303-1
  • 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
    It has come to the attention of specsavers that a batch of 74 boxes of 30 easyvision 'umere' daily contact lenses have been incorrectly labelled as -6.50 prescription lenses when in fact they were - 4.50 lenses. affected lenses were supplied only to specsavers' online customers between 1 october 2014 and 20 february 2015.
  • Acción
    Customers will be asked to identify whether they hold an affected box of contact lenses and the customer will be requested to return these in a post paid Toll bag provided by Specsavers. Specsavers will be sending replacement stock to all customers. For further information, please see https://www.tga.gov.au/alert/specsavers-easyvision-umere-daily-contact-lenses.

Device

Easyvision Umere Daily Contact Lenses (-6.50)30 x lenses for daily wear
  • Modelo / Serial
    Easyvision Umere Daily Contact Lenses (-6.50)30 x lenses for daily wearLot number R0031987 ARTG number: 186961
  • Manufacturer
    Specsavers Pty Ltd

Manufacturer

Specsavers Pty Ltd