Events

Rappel de Rayner Intraocular Lenses - Sulcoflex Aspheric 653L, Sulcoflex Torie 653T, C-flex Aspheric 970C, Superflex Aspheric 920H, Sulcoflex Aspherie 653L, T-flex Aspheric 623T

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Kevin Grundy (IBD) Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2016-RN-00044-2
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2016-01-13
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00044-2
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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, ...
  • Modèle / numéro de série
    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