Events

Alerta De Seguridad para CONSTELLATION VISION SYSTEM; Registration 80153480085; CULVER CHANGE SYSTEM - Registration 80147540177. Lots: Attachment - Distribution Map

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por ALCON LABORATÓRIOS DO BRASIL LTDA.; 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
    1667
  • Fecha
    2015-08-20
  • 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
    According to the company's statement, the loss of intraocular fluid through a cannula or sclerotomy during surgery can cause fluctuations in intraocular pressure. To avoid changes in intraocular pressure (IOP), use of the IOP control feature of the CONSTELLATION® Vision System can be used during surgery, or a plug can be inserted into the valve cannula.
  • Causa
    The company alcon has identified that some specific batches of valve cannulas have the possibility to leak through its format. the product is sold as a single item or as part of the constellation® equipment kit.
  • Acción
    The company that holds the registration in Brazil will take corrective action providing individual plugs to be used with the valve cannula, in cases where an excessive leak is identified during the use of the affected kit. For more information, contact the company. Phone: (11) 3732-4023

Device

CONSTELLATION VISION SYSTEM; Registration 80153480085; CULVER CHANGE SYSTEM - Registration 801475...

Manufacturer

ALCON LABORATÓRIOS DO BRASIL LTDA.; ALCON LABORATORIES, INC
  • Empresa matriz del fabricante (2017)
    Novartis Ag
  • Source
    ANVSANVISA