Alerta De Seguridad para Alcon AcrySof CACHET PHAKIC Lens

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Alcon Laboratories Inc.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2014-09-25
  • Fecha de publicación del evento
    2014-09-24
  • País del evento
  • Fuente del evento
    DH
  • URL de la fuente del evento
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: alcon acrysof cachet phakic lens the australia therapeutic goods administration (tga) posted a medical device safety alert concerning acrysof cachet phakic lens manufactured by alcon laboratories inc. the manufacturer is discontinuing the sale of the cachet phakic lens based on data analysis from an ongoing 10-year study to evaluate the safety of the cachet phakic lens in patients with myopia (near-sightedness) from -6.0 to -16.5 d vision correction. according to the manufacturer, the clinical data analysis indicates an increase in the number of cases of endothelial cell loss (ecl). in the clinical study, patients’ endothelial cell density (ecd) levels are monitored at 6 month intervals, as recommended by the current cachet phakic lens directions for use (dfu). to date, only 2.7% of the 1,323 cachet phakic lenses implanted in the clinical study were explanted due to ecl. for patients with the cachet phakic lenses already implanted, the manufacturer recommends adherence to the monitoring requirements described in the current dfu. adherence to these requirements by patients will help to timely identify significant ecl and determine the appropriate treatment plan. for details, please refer to the following tga website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2014-rn-01013-1 according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 24 september 2014.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Alcon AcrySof CACHET PHAKIC Lens
  • Manufacturer

Manufacturer