Events

Alerta De Seguridad para ACUVUE soft contact lenses

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Johnson & Johnson Vision Care, 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
  • Fecha
    2017-10-23
  • Fecha de publicación del evento
    2017-10-23
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20171023.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
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: johnson & johnson acuvue soft contact lenses contact lenses manufacturer, johnson & johnson vision care, inc., is recalling certain lots of its acuvue disposable soft contact lenses. the affected products are as follows:- product names: a) 1-day acuvue moist; b) acuvue advance with hydraclear; c) acuvue oasys with hydraclear plus; d) acuvue oasys with hydraclear plus for astigmatism lot numbers: a) 2836840101, 2836840102; b) b00dhlp; c) l002ncs; d) b00hrmg, b00gw4z according to the manufacturer, the affected products do not meet its quality standards. nonetheless, there are no significant health risks related to the affected products. the reasons for the recall are shown below: 1-day acuvue moist associated with a limited number of confirmed reports of a temporary sensation of stinging in the eye when the contact lens is inserted. acuvue advance with hydraclear and acuvue oasys with hydraclear plus associated with a limited number of reports of a brush bristle – previously used in the manufacturing process – found between the blister package and foil. the brush has been removed from the manufacturing process and replaced with alternative, safety-tested equipment. acuvue oasys with hydraclear plus for astigmatism associated with a limited number of confirmed reports of a lens being “off power” which the consumer may recognize as distortion or blurriness. the manufacturer has suspended shipment of the affected products, while the optical outlets are advised to check their inventory immediately and isolate the affected products. product recall and replacement are on-going. according to the local supplier, the affected products are distributed in hong kong. a customers’ hotline has been setup by the local supplier for enquiries: 2588 1100. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 23 october 2017.

Device

ACUVUE soft contact lenses

Manufacturer

Johnson & Johnson Vision Care, Inc.