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
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Voluntary recall of single-use contact lenses the department of health (dh) was notified by johnson & johnson (hk) limited today (august 19) that a voluntary recall of 16 batches of contact lens 1 day acuvue trueye is underway due to potential eye irritation or discomfort as a result of using the product. a dh spokesman said the affected batch was manufactured in ireland with lot numbers - 492237, 492238, 492241, 492245, 492250, 492251, 492252, 492254, 492268, 492280, 492281, 492282, 492283, 492287, 492288 and 492289. these numbers are the first six digits of the lot number printed at the side of the product box. according to johnson & johnson, the recall followed complaints regarding "unusual stinging or pain upon inserting of lens" reported in japan, which included stinging, ocular pain, redness and irritation. the investigation of the manufacturer so far showed that there was a problem in one portion of the lens rinsing process on a particular manufacturing line during a certain period of time. in hong kong, there has so far been no reported adverse events arising from use of the affected batches. according to the local supplier, about 3,715 boxes of the affected batches have been shipped out to optical outlets. the spokesman advised that members of the public should stop using the affected product and contact the company at their hotline, 2963 6799, for recall and product replacement. the hotline will operate from august 20 until september 22, daily between 9am and 6pm. the recall details can also be accessed at the website: www.Acuvue.Com.Hk. those who feel unwell after using the product should seek advice from their healthcare professionals. meanwhile, the dh has informed both public and private hospitals, relevant medical associations and optometrist associations about the issue. the recall will be closely monitored. ends/thursday, august 19, 2010.


  • Modelo / Serial
  • Descripción del producto
    Press release: Contact lens problems
  • Manufacturer