Events

Retiro De Equipo (Recall) de AcrySof CACHET Phakic Lens (Intraocular lens used for the reduction or elimination of myopia)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Alcon Laboratories 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-2012-RN-00693-3
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-07-11
  • 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-2012-RN-00693-3
  • 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 is an update to the previous ‘urgent recall for product correction/hazard alert for surgeons’, dated 20th february 2012 (tga ref:rc-2012-rn-00145-3) issued by alcon, and is intended to further inform about an adverse event associated with the alcon acrysof cachet phakic lens and additional information gained through the studies allows an update to the directions for use (dfu). the updates to dfu are primarily associated with:– clarification that the lens is indicated for use for the correction of myopia between -6.0 d and -16.5 d.– additional information regarding the risk of acute endothelial cell loss (ecl) to strengthen communication of benefits and risks of implantation to the patient– clarification on the frequency of monitoring for ecl by specular microscopy– data on patients who experienced a greater than 30% endothelial cell loss (when compared to the preoperative cell count) and/or count below 1500 cells/mm² in the clinical studies.
  • Acción
    Customers to be aware of the updated safety information provided in the revised Directions for Use. Physicians are advised to follow the recommended post-operative follow-up schedule as outlined in the Hazard Alert letter.

Device

AcrySof CACHET Phakic Lens (Intraocular lens used for the reduction or elimination of myopia)
  • Modelo / Serial
    AcrySof CACHET Phakic Lens (Intraocular lens used for the reduction or elimination of myopia)ARTG Number: 159641
  • Manufacturer
    Alcon Laboratories Australia Pty Ltd

Manufacturer

Alcon Laboratories Australia Pty Ltd