Alerta De Seguridad para Trade name: Pentacam. Technical name: Scheimpflug analyzer for ophthalmology. ANVISA registration number: 80039200010. Class of risk: II. Affected model: Pentacam, Pentacam HR and Pentacam AXL. Serial numbers affected: 70100 0041 7160 70100 3121 6190 70100 5121 6190 70100 7611 6170. 70100 0511 6170 70100 3611 6170 70100 5221 6101 70100 8221 6101. 70100 1321 6101 70100 4021 6190 70100 5231 7130 70100 8521 6111. 70100 1711 6170 70100 4321 6101 70100 6211 6150. 70100 1931 7150 70100 4811 6190 70100 7121 6190

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Tecnicall Comércio, Importação e Exportação LTDA; Oculus Optikgeräte Gmbh Münchholzhäuser.

¿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
  • Fecha
  • País del evento
  • Fuente del evento
  • 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
    The recommendation was to update the software so that this information no longer occurs during the scanning of the eye. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Additional information: - Date of identification of the problem by the company: 11/15/2017 - Date of notification notice to Anvisa: 12/19/2017 The company that owns the affected product is responsible for contacting its customers in due time. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
  • Causa
    It was recently determined that when a specific workflow sequence to perform energy calculation is used, the color display of the qs value changes from yellow to white while the output values ​​remain the same. the result is that the interpretation of the data, only considering the qs value, changes from "verify measurement results; repeat measurement if in doubt" (indicated in yellow) for "measurement is ok" (signaled in white). although the device has a secondary warning (plausibility check) that signals any difference in axial length greater than 0.3mm, indicating with warning and displaying the suspected axial length difference, the company determined that this workflow sequence could result, in rare cases, wrong output display.
  • Acción
    Field Action Code 1 triggered under the responsibility of Tecnicall Comércio, Importação e Exportação LTDA. Will make field correction