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
    108435
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-04-02
  • 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
    This notice is being provided to update the healthcare professionals on the actions alcon is taking concerning the alcon acrysof cachet phakic lens. this is further update to the communications alcon issued in february 2012 and july 2012 where they described updates to the directions for use (dfu) and advised healthcare professionals of an acute adverse event for endothelial cell loss (ecl). alcon is developing a plan of action to ensure that physicians have the information they need to appropriately treat and monitor patients and that patients can make an informed choice about their treatment. while this is taking place and until further guidance is issued alcon is voluntarily suspending shipment of the acrysof cachet phakic lens from their facilities. the study data showed high efficacy as defined by visual acuity but a small subset of patients (approximately 1% of implanted lenses to date) showed a risk for accelerated corneal endothelial cell loss (ecl) that led to explantation of the lens. the company is currently discussing a plan of action with the health authorities.

Device

ACRYSOF CACHET PHAKIC LENS
  • Modelo / Serial
    Model Catalog: L13000 (Lot serial: ALL LOTS); Model Catalog: L13500 (Lot serial: ALL LOTS); Model Catalog: L14000 (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