Events

Alerte De Sécurité sur Catalys Precision Laser System

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Abbott Medical Optics.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2015-03-16
  • Date de publication de l'événement
    2015-03-17
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150316a.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: abbott medical optics catalys precision laser system medical device manufacturer, abbott medical optics, has issued a medical device safety alert concerning catalys precision laser system [software version: 3.00.05]. the manufacturer identified two issues: loss of suction during treatment which may result in scoring the cornea during lens fragmentation. for the cataract incision surgeon templates with software version 3.00.05, selecting and deselecting an eye then selecting the other eye will result in templates for both eyes having the same parameters. the manufacturer has provided instructions on how to detect and respond to loss of suction, and advised users to verify the parameters, architecture and location of the cataract incisions in the cataract incision surgeon templates before saving and before treatment. the manufacturer will provide a software update to resolve the second issue. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 17 march 2015.

Device

Catalys Precision Laser System
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Abbott Medical Optics Catalys Precision Laser System
  • Manufacturer
    Abbott Medical Optics

Manufacturer

Abbott Medical Optics