Events

Rappel de AcrySof CACHET Phakic Lens (Intraocular lens used for the reduction or elimination of myopia)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Alcon Laboratories Australia 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-2012-RN-00693-3
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2012-07-11
  • 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-2012-RN-00693-3
  • 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
    This is an update to the previous ‘urgent recall for product correction/hazard alert for surgeons’, dated 20th february 2012 (tga ref:rc-2012-rn-00145-3) issued by alcon, and is intended to further inform about an adverse event associated with the alcon acrysof cachet phakic lens and additional information gained through the studies allows an update to the directions for use (dfu). the updates to dfu are primarily associated with:– clarification that the lens is indicated for use for the correction of myopia between -6.0 d and -16.5 d.– additional information regarding the risk of acute endothelial cell loss (ecl) to strengthen communication of benefits and risks of implantation to the patient– clarification on the frequency of monitoring for ecl by specular microscopy– data on patients who experienced a greater than 30% endothelial cell loss (when compared to the preoperative cell count) and/or count below 1500 cells/mm² in the clinical studies.
  • Action
    Customers to be aware of the updated safety information provided in the revised Directions for Use. Physicians are advised to follow the recommended post-operative follow-up schedule as outlined in the Hazard Alert letter.

Device

AcrySof CACHET Phakic Lens (Intraocular lens used for the reduction or elimination of myopia)
  • Modèle / numéro de série
    AcrySof CACHET Phakic Lens (Intraocular lens used for the reduction or elimination of myopia)ARTG Number: 159641
  • Manufacturer
    Alcon Laboratories Australia Pty Ltd

Manufacturer

Alcon Laboratories Australia Pty Ltd