Events

Retiro De Equipo (Recall) de ACRYSOF CACHET PHAKIC LENS

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

¿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
    95185
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-08-08
  • 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
    The directions for use will be revised to include the following information: -clarification that the acrysof cachet phakic lens is indicated for use for the correction of myopia between -6.0 d and -16.5 d. -additional information regarding the risk of early acute endothelial cell loss (ecl) to strengthen communication of benefits and risks of implantation to the patient. -clarification on the frequency of monitoring for ecl by specular microscopy. the new recommendation is applicable for post-operative follow-up at one month three months and six months and then at six-month intervals in collaboration with the treating physician. -data on patients who experienced a greater than 30% endothelial cell loss (when compared to the preoperative cell count) and/or count below 1500 cells/mm2 in the clinical studies.

Device

ACRYSOF CACHET PHAKIC LENS
  • Modelo / Serial
    Model Catalog: L14000 (Lot serial: ALL LOTS); Model Catalog: L13500 (Lot serial: ALL LOTS); Model Catalog: L13000 (Lot serial: ALL LOTS); Model Catalog: L12500 (Lot serial: ALL LOTS)
  • Descripción del producto
    ACRYSOF CACHET PHAKIC LENS
  • Manufacturer
    ALCON CANADA INC.

Manufacturer

ALCON CANADA INC.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Novartis Ag
  • Source
    HC