Events

Retiro De Equipo (Recall) de KAMRA Corneal Inlay (inserted into the natural cornea to treat presbyopia ie, age related hyperopia (far sightedness))

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Ellex 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-2013-RN-01254-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-12-13
  • 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-2013-RN-01254-1
  • 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
    The manufacturer, acufocus is aware of reports of some cases involving use of ophthalmic laser applications in eyes containing kamra inlays. during laser treatment, the inlay may absorb the laser and produce heat. this may result in the inlay reducing in size and/or significant thermal damage. in some cases, there were secondary damage to the cornea resulting in scarring. as a result of these case reports, ellex is providing additional warnings and information relative to the application of various ophthalmic procedures with a kamra inlay in situ.
  • Acción
    The manufacturer has advised the inlays are not defective and function as intended. The purpose of this notification is to provide additional warnings and information with regard to further treatment to patients implanted with the KARMA inlay.

Device

KAMRA Corneal Inlay (inserted into the natural cornea to treat presbyopia ie, age related hyperop...
  • Modelo / Serial
    KAMRA Corneal Inlay (inserted into the natural cornea to treat presbyopia ie, age related hyperopia (far sightedness))ARTG Number: 182104
  • Manufacturer
    Ellex Australia Pty Ltd

Manufacturer

Ellex Australia Pty Ltd