Events

Alerta De Seguridad O Notificaciones De Seguridad para Ophthalmic implant Raindrop Near Vision Inlay

Según Medicines and Healthcare products Regulatory Agency, este evento ( alerta de seguridad o notificaciones de seguridad ) involucró a un dispositivo médico en United Kingdom que fue producido por ReVision Optics, 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
    Safety alert / Field Safety Notice
  • Fecha
    2018-02-13
  • Fecha de publicación del evento
    2019-02-13
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://www.gov.uk//drug-device-alerts/ophthalmic-implant-raindrop-near-vision-inlay-risk-of-corneal-haze-mda-2019-007
  • Notas / Alertas
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Notas adicionales en la data
    The USA’s Food and Drug Administration (FDA) issued a safety communication informing users that implantation of this device has led to an increased occurrence of corneal haze.The cited study shows that 75% of 150 enrolled patients developed corneal haze. In 42% of patients, the corneal haze has been present in the central region of the cornea.There is no specific guidance regarding frequency of follow-up from the manufacturer; the clinician should assess the risk of corneal haze in individual patients.It is unknown how many Raindrop Near Vision Inlay devices may be placed on the market in the UK.
  • Causa
    Manufactured by revision optics, inc – patients implanted with this device have an increased risk of corneal haze.
  • Acción
    Do not implant Raindrop Near Vision Inlays. Identify all unused stock of Raindrop Near Vision Inlays and dispose of them. Monitor patients who have the inlay implanted or have previously had the device explanted for the development of corneal haze. The frequency of follow up should be determined by individual patient risk assessment. Report adverse events involving these devices through your local incident reporting system and/or your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales. You should also report directly to manufacturers if your local or national systems do not.

Device

Ophthalmic implant Raindrop Near Vision Inlay
  • Modelo / Serial
  • Descripción del producto
    The device is a corneal inlay (corneal implant) used to improve near vision.
  • Manufacturer
    ReVision Optics, Inc

Manufacturer

ReVision Optics, Inc
  • Dirección del fabricante
    ReVision Optics, the manufacturer of this device, ceased operations in 2018 and no contacts are available. Due to the lack of information on the distribution of this device, the MHRA is publishing this alert as a precautionary notice.
  • Empresa matriz del fabricante (2017)
    ReVision Optics Inc.
  • Source
    MHRA