Events

Retiro De Equipo (Recall) de LenSx Laser System (used for femtosecond cataract surgery)

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-2014-RN-00424-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-04-10
  • 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-2014-RN-00424-1
  • 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
    Alcon is addressing reports of unexpected downward motion of the gantry. these reports are associated with systems manufactured with an older style motor/brake assembly. a new style motor/brake assembly (current version) has been used in manufacturing since may 2012. of the 41 reports, contact with the patient's eye or face was reported in three instances. in all of these cases, the contact with patient eye resulting from the unexpected downward gantry motion did not lead to a serious injury or a serious deterioration in state of health.
  • Acción
    If customers experience any unexpected gantry movement, they are advised to immediately notify Alcon and stop using the LenSx Laser System. Alcon will replace and install the current motor/brake assembly on any impacted LenSx Laser System manufactured prior to May 2012, including those that have not been previously upgraded.

Device

LenSx Laser System (used for femtosecond cataract surgery)
  • Modelo / Serial
    LenSx Laser System (used for femtosecond cataract surgery) Serial numbers: 0611-A020, 0711-A022, 1011-A053, 1011-A060, 0312-A123ARTG Number: 181017
  • Manufacturer
    Alcon Laboratories Australia Pty Ltd

Manufacturer

Alcon Laboratories Australia Pty Ltd