Events

Alerta De Seguridad para Contact Lenses FreshLook Toric Phemfilcon A. Identifiers: BC Median; 14.5-Diameter; Lot No. 041599; Validity JAN 2007

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por CIBA Vision Corp.

¿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
    690
  • Fecha
    2003-03-07
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    The above mentioned contact lenses may be wrongly labeled. the manufacturer initiated a notification by letter dated 16 december 2002.
  • Acción
    Make sure you have received the letter from CIBA Vision on December 16, 2002. Identify and isolate any affected product in your inventory. For additional information, contact CIBA Vision in the USA at (678) 415-3937. ANVISA has provided the Occurrence Notification Forms on the Internet http://www.anvisa.gov.br/sistec/notificacaoavulsa/notificacaoavulsa1.asp so that you notify if there are any problems with the products in your inventory. For further information, please contact ANVISA's Tecnovigilância Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485.

Device

Contact Lenses FreshLook Toric Phemfilcon A. Identifiers: BC Median; 14.5-Diameter; Lot No. 04159...

Manufacturer

CIBA Vision Corp
  • Empresa matriz del fabricante (2017)
    Novartis Ag
  • Source
    ANVSANVISA