Events

Retiro De Equipo (Recall) de VERION Reference Unit (Vision Planner) - used with the Alcon LenSx Laser System (Surgery planning system for ophthalmic 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-2016-RN-00255-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-03-08
  • 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-2016-RN-00255-1
  • 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 has received reports concerning the inclusion of unplanned arcuate incisions on printed, saved (.Pdf) or exported surgical plans. this situation only occurs when the verion reference unit (vision planner) is used to create a surgical plan for non-alcon toric intraocular lenses (iols) that is used with the alcon verion digital marker lensx laser system. surgical plans for alcon toric iols as well as all spherical iol regardless of brand are not affected. these unintentional surgical plan arcuates can occur if the deactivated ‘iol 100% – ri 0%’ slider bar is unintentionally activated by the user in the planning software. this directs the software to include the addition of arcuates for the surgical procedure and can only be seen on the exported, saved (.Pdf) or printed surgical plans. if the additional arcuates are performed this may lead to an astigmatism overcorrection resulting in reduced unaided visual acuity.
  • Acción
    Alcon is providing users with work around instructions to follow as an interim measure. A software update will be installed on all affected systems as a permanent fix.

Device

VERION Reference Unit (Vision Planner) - used with the Alcon LenSx Laser System (Surgery planning...
  • Modelo / Serial
    VERION Reference Unit (Vision Planner) - used with the Alcon LenSx Laser System (Surgery planning system for ophthalmic surgery)Catalogue Number: 8065998240ARTG Number: 214732
  • Manufacturer
    Alcon Laboratories Australia Pty Ltd

Manufacturer

Alcon Laboratories Australia Pty Ltd