Events

Alerta De Seguridad para Rayner acrylic intraocular lenses

Según National Institute of Drugs and Food Surveillance (INVIMA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Colombia que fue producido por Rayner Intraocular Lenses Limited.

¿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
  • ID del evento
    R1601-17
  • Número del evento
    2014DM-0002413-R1
  • Fecha
    2016-01-14
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=161
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notas adicionales en la data
  • Causa
    The manufacturer reports that it has detected that internal quality tests have revealed that the products referenced and placed on the market may contain a residual level of an auxiliary polisher used in the manufacture of the medical device, above the normal limits, leading to potentially adverse events occurring on the patients.

Device

Rayner acrylic intraocular lenses
  • Modelo / Serial
    C-flex Aspheric, Sulcoflex Aspheric, Sulcoflex Toric, Sulcoflex Aspheric and T-flex Aspheric ", specific serials.
  • Descripción del producto
    SULCOFLEX lenses are contraindicated in patients in whom safe placement in the desired area can not be achieved. The absence of the peripheral capsule is safe, the lack of intact zonules, unusual oregular anatomy of the ciliary sulcus. Warnings: the unusual oregular anatomy of the ciliary sulcus can cause a postoperative regional displacement of the bundle. In such a case the mess can be realigned or fixed by suture. An iridiotomy or iridectomy may be necessary. Precautions and warnings: check the integrity of the sterile barrier system before deusing. Do not use if the barrier system is damaged. Do not sterilize. For sole use only. The single-use intraocular lens can not be used again since it is not designed to work as intended after the first and only use. Changes in mechanic, physical and chemical characteristics under conditions of repeated use, cleaning and resterilization will compromise the integrity of the intraocular lens.
  • Manufacturer
    Rayner Intraocular Lenses Limited

Manufacturer

Rayner Intraocular Lenses Limited