Alerta De Seguridad para CATALYS LASER SYSTEM FOR CATARACT SURGERY, Record: 80147060156; Risk class III, Lot number: 44067514 (01 equipment marketed in Brazil)

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Abbott Produtos Óticos Ltda.; OPTIMEDICA CORPORATION..

¿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
    1566
  • Fecha
    2015-03-25
  • 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
    According to the company the possible consequences of the failure are: 1) Potential marking in the Cornea due to Suction Loss; 2) Incorrect Cataract Incision Mode Potential by Surgeon.
  • Causa
    According to data from the registry holder, 2 questions related to the catalys® system software version 3.00.05: 1 were identified; being: 1) loss of suction during treatment may lead to a marking of the cornea, during crystalline fragmentation; 2) change in cataract incision mode with software in version 3.00.05. selecting and deselecting one eye and then selecting the other eye will result in modes with the same parameters for both eyes.
  • Acción
    The company directs: A) continuously monitor the video image immediately before and during each laser treatment, looking for blisters or other indications of loss of suction. If a blister or abnormality is observed, remove the foot from the laser pedal immediately to stop the treatment. B) Check that the LIQUID OPTICS Interface remains completely filled with sterile balanced physiological solution throughout the procedure. If the CATALYS® System detects forces out of acceptable levels or loses suction during laser treatment, follow the instructions for continued treatment as described in the Operator's Manual or consider switching to traditional cataract surgery. If the laser treatment has not yet begun, check the fluid collection and consider reapplying the suction ring to the patient's eye. C) Verify that the cataract incisions in the cataract incision models by the surgeon have the correct parameters, the correct architecture and are in the desired location before saving. D). During the treatment planning phase and before activating the laser, check that all treatment incisions have the correct parameters, the correct architecture and whether they are in the desired location shown on the screen.

Manufacturer