Events

Alerta De Seguridad para Probes for ophthalmic equipment, model Sonda Accurus 2500, registry 80153480154 and model Probe Accurus 23 Gauge, registry 80153480154. Class of risk II. ///// Affected lots: Accurus 2500 probe - Sold: 14017452X; 14026030X; - In stock: 14031263X; 14033833X. /// Affected lots: Accurus 23 GAUGE probe - Sold: 14010428X; 14012987X; 14014736X; 14016577X; 14017912X; 14022920X; 14026031X; 14028553X; - In stock: 14033830X; 14036306X; 15010057X.

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
    1610
  • Fecha
    2015-06-10
  • 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 registry holder, the use of the non-sterile vitrectomy catheter in ophthalmologic surgery presents a risk of triggering a process of inflammation and infection in the patient. To date, no adverse events have been reported.
  • Causa
    It has been identified that the seal on the outer carton is insufficient and may affect the sterility of the product.
  • Acción
    The company will send a letter to the customers informing them about the voluntary collection of the products. Products should not be used.

Device

Probes for ophthalmic equipment, model Sonda Accurus 2500, registry 80153480154 and model Probe A...

Manufacturer

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