Events

Retiro De Equipo (Recall) de Healon Ophthalmic Viscosurgical Devices (OVD) 0.55mL

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por AMO 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-2017-RN-00525-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-04-26
  • 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-2017-RN-00525-1
  • 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
    Amo has identified the remote possibility that certain healon 0.55ml solutions in the affected lot may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process. use of ovd solutions with glass particles could potentially lead to intraocular injury. to date, no patient injuries have been reported to amo in connection with any of the affected healon 0.55ml.
  • Acción
    AMO Australia is advising users to immediately stop using and remove the affected Healon 0.55ml lot from their inventory. Distributors are to stop shipping this lot. Product is to be returned to AMO for replacement.

Device

Healon Ophthalmic Viscosurgical Devices (OVD) 0.55mL
  • Modelo / Serial
    Healon Ophthalmic Viscosurgical Devices (OVD) 0.55mLLot Number: UB32514ARTG Number: 144891
  • Manufacturer
    AMO Australia Pty Ltd

Manufacturer

AMO Australia Pty Ltd