Events

Rappel de Catalys Precision Laser System

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par AMO 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-2015-RN-00240-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-03-19
  • 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-2015-RN-00240-1
  • 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
    Abbott medical optics is providing this notification to all customers who use the catalys system software version 3.00.05 to make you aware of two issues:1. loss of suction during treatmenta low probability event has been identified where loss of suction during treatment may result in scoring the cornea during lens fragmentation.The catalys system has mitigations within its design to prevent this event from occurring, if the system detects a loss of vacuum or forces outside of theacceptable range, the system will stop the laser from activating during treatment and displays a message.2. auto-population of cataract incision templatea low probability event has been identified for the cataract incision surgeon templates with software version 3.00.05, when selecting and deselecting an eye then selecting the other eye will result in the templates for both eyes having the same parameters. this event only affects the cataract incisionsurgeon templates.
  • Action
    AMO is advising that to prevent the incorrect auto-population of cataract incision templates end users must: a) Verify the cataract incisions in the cataract incision a surgeon templates have the correct parameters, correct architecture and are in the desired location prior to saving. b) Within the treatment planning phase and prior to activating the laser, verify all treatment incisions have the correct parameters, correct architecture and are in the desired location which are displayed on the screen. This issue will be corrected in a software update. AMO is also reinforcing the instructions for use with regard to suction loss. This action has been closed-out on 1/06/2016.

Device

Catalys Precision Laser System
  • Modèle / numéro de série
    Catalys Precision Laser System Serial Numbers: 44056912, 44055711, 44072214, 44061512, 44057612ARTG Number: 194204
  • Manufacturer
    AMO Australia Pty Ltd

Manufacturer

AMO Australia Pty Ltd