Events

Retiro De Equipo (Recall) de AcrySof CACHET Phakic Lens (Used for the reduction or elimination of myopia)

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-2013-RN-00300-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-04-05
  • 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-2013-RN-00300-1
  • 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
    This action is an update to the previous ‘urgent recall for product correction' and 'hazard alert' letters issued by alcon in february 2012 and july 2012 for the acrysof cachet phakic lens that described updates to the directions for use (dfu) and advised healthcare professionals of an acute adverse event for endothelial cell loss (ecl). recently alcon conducted a further data analyses of the five-year global study looking at the safety and efficacy of the acrysof cachet phakic lens. whilst the study data showed high efficacy as defined by visual acuity, approximately 1% of implanted lenses showed a risk for accelerated corneal endothelial cell loss (ecl) that led to explantation of the lens. the cause of ecl in individual patients is not well understood and is likely multi-factorial. however, analyses have indicated a trend for higher rates of ecl in:- patients with smaller eyes (those implanted with lens model l12500) - patients self-identified as being asians.
  • Acción
    Alcon is revising Directions for Use (DFU) with: - updated clinical data to include results from 5 year clinical studies - strengthen language to require (endothelial cell density (ECD) assessment of every 6 months - provide guidelines for endothelial cell monitoring For patients with the AcrySof CACHET Phakic Lenses already implanted, Alcon is recommending surgeons to remind the patients of the risks associated with undetected ECL and also, discuss the need for strict compliance with the monitoring requirements endothelial cell density ie, monitoring every six months) per the current version of the Directions for Use (DFU). Strict adherence to these requirements by patients will help to timely identify ECL and determine the appropriate treatment plan.

Device

AcrySof CACHET Phakic Lens (Used for the reduction or elimination of myopia)

Manufacturer

Alcon Laboratories Australia Pty Ltd