Events

Retiro De Equipo (Recall) de Proclear Toric Soft Hydrophilic Contact Lenses

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Coopervision 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-2014-RN-01039-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-10-01
  • 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-2014-RN-01039-1
  • 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
    Coopervision's investigation of complaints have identified that a limited number of lots were manufactured with the cylinder axis outside the allowable specification. there is not likely to be added medical risk to an incorrect axis lens use, since the patient will notice the blur and visual disturbance right away and report it to the practitioner. replacement of the lens with the proper power parameter in sphere and cylinder, and/or axis of astigmatism will alleviate the visual blur and disturbance.
  • Acción
    Retailers (practitioners) are advised to stop any further patient order fulfilment of the affected lots of Proclear Toric lenses and quarantine them for returning it to Coopervision. Patients will be provided full refund for any affected product returned by them. This action has been closed-out on 17/05/2017.

Device

Proclear Toric Soft Hydrophilic Contact Lenses
  • Modelo / Serial
    Proclear Toric Soft Hydrophilic Contact LensesMultiple lot numbers manufactured in 2012ARTG number: 169193
  • Manufacturer
    Coopervision Australia Pty Ltd

Manufacturer

Coopervision Australia Pty Ltd