Events

Rappel de LaserEdge Knives

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par iNova Pharmaceuticals 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-2017-RN-00366-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-03-10
  • 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-2017-RN-00366-1
  • 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
    Inova pharmaceuticals (australia) pty ltd (inova) is conducting an urgent recall of 82 lots of 11 laseredge knife skus used in ophthalmic surgery due to an atypical number of dull blade complaints. if excessive force is required to push a dull blade through the cornea this may result in a sub-optimal incision. uncontrolled penetration through the cornea may also result in injury to anterior segment structures.Patients undergoing posterior segment surgery (e.G. vitrectomy) are at potential risk for suprachoroidal haemorrhage or retinal injury which, in rare instances, may be associated with permanent loss of vision. the likelihood of adverse events associated with dull blades is very low.
  • Action
    Customers are notified to inspect their stock immediately and quarantine affected stock of LaserEdge knives. iNova (Bausch + Lomb) will arrange for the stock return and provide a credit for the stock returned.

Device

LaserEdge Knives

Manufacturer

iNova Pharmaceuticals Australia Pty Ltd