Alerta De Seguridad para Trade Name: LenSx Laser System /// registration: 80153480158 // risk class III Lot-series: 413-A364; 0713-A450; 0414-A727; 0714-A808; 0714-A802; 1213-A620; 1213-A621; 1213-A622; 1013-A535

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por NOVARTIS BIOCIENCIAS S.A; 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
    1939
  • Fecha
    2016-04-15
  • País del evento
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
  • 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
    Recommendations to Users and Patients of the Record Holder of This Product: "Incomplete flap cuts are known to occur during LASIK procedures and their 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. We are 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 flap edge. "
  • Causa
    Alcon is conducting a medical device correction involving all lensx laser system devices with flap activated after receiving reports of incomplete corneal flap, resulting in uncut areas at the flap edge. according to the record holder of this product, this situation has been confirmed in only a small number of equipment in the current version of the software. in view of this, alcon is informing all users of activated flap of this possibility and are updating 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 .
  • Acción
    Action code 8494: Letter sending to affected clients and Software update.

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Source
    ANVSANVISA