Events

Notificaciones De Seguridad De Campo acerca de ACUVUE® OASYS® for ASTIGMATISM

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por Johnson & Johnson Vision Care, Inc. .

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2017-10-26
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
  • Notas adicionales en la data
  • Causa
    The series number for acuvue® oasys® for astigmatism® contact lenses is indicated on the individual contact lens blister pack and for the six units, also in the bar code area on the back of each package.   jjvc has opted for voluntary recall in order to provide customers with the highest quality products. we received a number of confirmed reports of a "malfunctioning" lens, which was perceived by users as inaccurate vision correction in one eye (distorted or blurred vision). following the investigation, it was found that the inserts in the mold used for the manufacture were damaged in the manufacture of molds for the front and rear curves of the contact lenses. jjvc has introduced enhanced control over techniques for identifying damaged mold inserts. not all the lenses of the aforementioned series are damaged and the case poses no significant health risks.

Device

ACUVUE® OASYS® for ASTIGMATISM

Manufacturer

Johnson & Johnson Vision Care, Inc.