Events

Alerta De Seguridad para SKBM MICROCERATOMY - Registration ANVISA / MS: 10002390118. Composition: Console, Pedal, Handpiece (head, Steel Band, Motor, Blade), Suction Rings, Tube.

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.

¿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
    682
  • Fecha
    2002-11-25
  • 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
    Alcon is asking physicians to discontinue use of the product and to inform Alcon to remove the equipment. For more information, contact your local representative or directly with Alcon Laboratorios do Brasil Ltda at 11-3732-4103 or 11-3732-4119./////////////// ////////////////// - Brasilia-DF, 20.06.2003 - The company ALCON LABORATORIES DO BRASIL LTDA, informs that the recall process of the MICROCERATOMO SKBM product market, was completed.
  • Causa
    Degradation of the "epoxy" adhesive that supports the applanation window. this movement could represent a potential risk to the patient due to the lack of control over the depth of incision.
  • Acción
    The company informs that it is conducting, voluntarily, the collection of the equipment.

Device

SKBM MICROCERATOMY - Registration ANVISA / MS: 10002390118. Composition: Console, Pedal, Handpiec...

Manufacturer

Alcon Laboratórios do Brasil Ltda
  • Source
    ANVSANVISA