Events

Retiro De Equipo (Recall) de IFS ADVANCED FEMTOSECOND LASER

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por AMO CANADA COMPANY.

¿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
    17570
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2011-10-27
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Abbott medical optics inc. initiated this event after becoming aware of a discrepancy in cut depth that may affect deep corneal incisions (e.G. 300 micrometres or deeper) created using the femtosecond laser system. this discrepancy between the user-set depth of corneal tissue incision and the actual depth of those incisions was discovered during an engineering investigation conducted prior to the launch outside the united states of a new indication for arcuate incision procedures. the engineering investigation was not initiated due to the receipt of a complaint.

Device

IFS ADVANCED FEMTOSECOND LASER
  • Modelo / Serial
    Model Catalog: MODEL IFS (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: FS (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: MODEL 2 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Descripción del producto
    IFS ADVANCED FEMTOSECOND LASER
  • Manufacturer
    AMO CANADA COMPANY

Manufacturer

AMO CANADA COMPANY
  • Dirección del fabricante
    MARKHAM
  • Empresa matriz del fabricante (2017)
    Amo Canada Company
  • Source
    HC