Events

Alerta De Seguridad para 1 Day Acuvue TruEye

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Johnson & Johnson.

¿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
  • Fecha
    2010-08-20
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/press_20100823.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notas adicionales en la data
    Press release
  • Causa
    Contact lens problems in response to media enquiries, a spokesman for the department of health (dh) said information provided by johnson & johnson (hk) limited indicated that the problem of its 1 day acuvue trueye which led to a recall of 16 batches of the product was caused by failure to remove a diluent during the rinsing process. according to johnson & johnson,the affected lots may contain lenses with trace amount of diluent agent that is intended to be extracted from the lens during the rinsing process. due to a mechanical failure in the rinsing process this extraction was not complete. this diluent agent is an intended part of the 1day acuvue trueye formulation and therefore is not considered a contaminant. in relation to the recall, the spokesman added that johnson & johnson had been asked to deploy more staff to man its enquiry hotline and speed up recall and product replacement. the spokesman said: "dh's investigation continues and the recall will be closely monitored." 20 august 2010.

Device

1 Day Acuvue TruEye
  • Modelo / Serial
  • Descripción del producto
    Press release: Contact lens problems
  • Manufacturer
    Johnson & Johnson

Manufacturer

Johnson & Johnson