Events

Alerta De Seguridad para Acrysof Cachet Phakic (Intraocular Lens). Anvisa Registry n ° 80147540167. Models at risk: L12500, L13000, L13500 and L14000.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Novartis Biociências; 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
  • ID del evento
    1443
  • Fecha
    2014-10-23
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notas adicionales en la data
    The analysis of the clinical data performed by the company indicated an increase in the number of cases of endothelial loss (ECL) among patients with severe myopia. None of the study patients had permanent loss of vision. See details in the Safety Communication disclosed by the company, available at http://portal.anvisa.gov.br/wps/wcm/connect/be33848045efe1f4a03ba47ffa9843d8/Communicado+de+Seguran%C3%A7a.PDF?MOD=AJPERES.
  • Causa
    Increased endothelial loss (ecl) among patients with severe myopia.
  • Acción
    The company is discontinuing the commercialization of the product. Patients with implanted Cachet Phakic lenses should continue to be monitored and evaluated constantly as described in the current Directions for Use of the product.

Device

Acrysof Cachet Phakic (Intraocular Lens). Anvisa Registry n ° 80147540167. Models at risk: L12500...

Manufacturer

Novartis Biociências; Alcon Laboratories, Inc.
  • Empresa matriz del fabricante (2017)
    Novartis Ag
  • Source
    ANVSANVISA