Events

Retiro De Equipo (Recall) de Lentis Foldable Intraocular Lenses (IOL)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Device Technologies Australia Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2017-RN-01194-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-09-13
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01194-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    The manufacturer oculentis has identified possible sporadic opacification of the intraocular lens (iol). studies conducted for oculentis have indicated that surface calcification could possibly be the result of phosphate remnants originating from a detergent previously used in the cleaning process of the iol. although the cause of iol opacification is multifactorial, remnants could make the iol under certain conditions more prone to opacification. the opacification may compromise the optical transparency of the iol in time, potentially leading to a slow reduction in the patient's visual acuity.
  • Acción
    1. For on-shelf units, users are to quarantine all affected stock, then complete and return the attached reply form fax to acknowledge receipt of this notice and advise your quantity of affected stock. 2. For implanted units there is no need for explanting or review of patients where the lens has been implanted. 3. In some cases, postoperative opacification of the IOL may present biomicroscopic aspects similar to posterior capsule opacification. Practitioners are advised to carefully evaluate each case to determine the exact nature of the cloudiness. 4. IOL exchange is the only recommended treatment for postoperative opacification if the visual acuity is compromised in view of the patient's individual conditions and needs.

Device

Lentis Foldable Intraocular Lenses (IOL)
  • Modelo / Serial
    Lentis Foldable Intraocular Lenses (IOL)Model Numbers starting with L-, LU- and LS- Expiry: between 2017-01 and 2020-05ARTG Number: 198807
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd