Events

Retiro De Equipo (Recall) de Rayner Intraocular Lenses - Sulcoflex Aspheric 653L, Sulcoflex Torie 653T, C-flex Aspheric 970C, Superflex Aspheric 920H, Sulcoflex Aspherie 653L, T-flex Aspheric 623T

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Kevin Grundy (IBD) 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-2016-RN-00044-2
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-01-13
  • 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-2016-RN-00044-2
  • 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
    Internal quality checks by the manufacturer rayner have revealed that certain products released to market may contain a higher than usual level of residual polishing compound (aluminium oxide) that is used in the manufacturing process of intraocular lenses (iols). there is a possibility that certain products released to market may contain levels that slightly exceed the internal limits for residual aluminium oxide levels. clinically significant levels of aluminium oxide have, on rare occasions been linked to cases of toxic anterior segment syndrome (tass) in published literature.
  • Acción
    Customers are advised to inspect their stock and quarantine all affected stock so that Designs For Vision Pty Ltd (distributor) can arrange for quarantined stock to be recovered and replacement stock, or a credit note, issued. Surgeons are advised that if a lens subject to this recall has been implanted, it is recommended that as a precaution, healthcare professionals monitor patients for up to one month post-operatively for symptoms of TASS, in case of late onset presentation. This action has been closed-out on 09/05/2017.

Device

Rayner Intraocular Lenses - Sulcoflex Aspheric 653L, Sulcoflex Torie 653T, C-flex Aspheric 970C, ...
  • Modelo / Serial
    Rayner Intraocular Lenses - Sulcoflex Aspheric 653L, Sulcoflex Torie 653T, C-flex Aspheric 970C, Superflex Aspheric 920H, Sulcoflex Aspherie 653L, T-flex Aspheric 623TMultiple Models and Lot Numbers affectedARTG Number: 100926
  • Manufacturer
    Kevin Grundy (IBD) Pty Ltd

Manufacturer

Kevin Grundy (IBD) Pty Ltd