Events

Retiro De Equipo (Recall) de LenSx Laser System with Corneal Flap Capability (used to perform corneal flaps in LASIK surgery or other treatment involving the incision of the cornea)

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-00522-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-04-27
  • 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-00522-1
  • 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 conducting a recall for product correction of all lensx laser systems with corneal flap capability after receiving reports concerning incomplete corneal flap creation, which manifests as un-dissected area(s) within the side cut. if an un-dissected area in the side cut is observed, it may cause difficulty lifting the flap, potentially resulting in corneal tear, irregular stromal bed, or a corneal epithelial defect. this issue has been confirmed to manifest in only a small number of systems through the normal installation setup and optimisation process.
  • Acción
    Alcon is advising users that the LenSx system can continue to be used, and to exercise professional medical judgement when determining the management of potential side cut issues. Alcon will be implementing a software upgrade in order to minimise any incomplete areas within the side cut. This action has been closed-out on 03/02/2017.

Device

LenSx Laser System with Corneal Flap Capability (used to perform corneal flaps in LASIK surgery o...
  • Modelo / Serial
    LenSx Laser System with Corneal Flap Capability (used to perform corneal flaps in LASIK surgery or other treatment involving the incision of the cornea)Catalogue Number: 8065998162 ARTG Number: 181017
  • Manufacturer
    Alcon Laboratories Australia Pty Ltd

Manufacturer

Alcon Laboratories Australia Pty Ltd