Events

Retiro De Equipo (Recall) de Catalys Precision Laser System

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por AMO 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-2015-RN-00240-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-03-19
  • 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-2015-RN-00240-1
  • 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
    Abbott medical optics is providing this notification to all customers who use the catalys system software version 3.00.05 to make you aware of two issues:1. loss of suction during treatmenta low probability event has been identified where loss of suction during treatment may result in scoring the cornea during lens fragmentation.The catalys system has mitigations within its design to prevent this event from occurring, if the system detects a loss of vacuum or forces outside of theacceptable range, the system will stop the laser from activating during treatment and displays a message.2. auto-population of cataract incision templatea low probability event has been identified for the cataract incision surgeon templates with software version 3.00.05, when selecting and deselecting an eye then selecting the other eye will result in the templates for both eyes having the same parameters. this event only affects the cataract incisionsurgeon templates.
  • Acción
    AMO is advising that to prevent the incorrect auto-population of cataract incision templates end users must: a) Verify the cataract incisions in the cataract incision a surgeon templates have the correct parameters, correct architecture and are in the desired location prior to saving. b) Within the treatment planning phase and prior to activating the laser, verify all treatment incisions have the correct parameters, correct architecture and are in the desired location which are displayed on the screen. This issue will be corrected in a software update. AMO is also reinforcing the instructions for use with regard to suction loss. This action has been closed-out on 1/06/2016.

Device

Catalys Precision Laser System
  • Modelo / Serial
    Catalys Precision Laser System Serial Numbers: 44056912, 44055711, 44072214, 44061512, 44057612ARTG Number: 194204
  • Manufacturer
    AMO Australia Pty Ltd

Manufacturer

AMO Australia Pty Ltd