Events

Alerta De Seguridad para Product trade name: LENSX LASER SYSTEM /// Record number: 80153480158 /// serial number affected: 0413-A364; 0713-A450; 0414-A727; 0714-A808; 0714-A802; 1213-A620; 1213-A621; 1213-A622; 1013-A535 / / / Product hazard class: III.

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
    1887
  • Fecha
    2016-04-26
  • 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
  • Causa
    Alcon is conducting a voluntary medical device correction involving all lensx laser system devices with flap activated after receiving reports regarding the performance of incomplete corneal flap, resulting in uncut areas at the flap edge.
  • Acción
    Classification of risk: II /// Classification of the field action: field correction with software update /// Field action code: 8494./// Recommendations: Incomplete flap cuts are known to occur during LASIK procedures and its Proper handling is part of the surgeon's training. We urge you to exercise your medical judgment in determining your level of comfort while handling potential cuts, which may occur as a result of your continued use of the LenSx Laser System in performing flap upgrades. According to the user manual of the LenSx Laser System, in the case of an incomplete laser treatment during the flap procedure, where a lateral cut is performed or not, it is advised that the corneal flap is not lifted. The surgeon should consider other medical options more suitable to complete the refractive treatment. The company is informing all users of flap upgrade of this possibility and we will update the software of all LenSx Laser System equipment that are used to perform corneal flap, in order to minimize the frequency of potentially incomplete areas at the edge of the flap.

Device

Product trade name: LENSX LASER SYSTEM /// Record number: 80153480158 /// serial number affected:...

Manufacturer

Novartis Biociências.; ALCON LABORATORIES, INC.
  • Empresa matriz del fabricante (2017)
    Novartis Ag
  • Source
    ANVSANVISA