Events

Alerte De Sécurité sur STAR S4 IR Excimer Laser System Software, Versions 5.00 through 5.22 and Versions 5.00 through 5.30

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 (AMO).

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
    2011-07-20
  • 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_20110720.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
    Advisory notice: abbott medical optics (amo) star s4 ir excimer laser system software, versions 5.00 through 5.22 and versions 5.00 through 5.30 abbott medical optics (amo) has issued an advisory notice to customers of amo star s4 ir excimer laser system and customers of amo wavescan wavefront system regarding a defect of the iris registration (ir) software on the star s4 ir excimer laser system, versions 5.00 through 5.22 and versions 5.00 through 5.30 respectively. there is a malfunction of the compensation for pupil centroid shift in the affected software versions, which may lead to visual disturbances or reduced best corrected visual acuity. according to the local supplier, the affected products are available in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

STAR S4 IR Excimer Laser System Software, Versions 5.00 through 5.22 and Versions 5.00 through 5.30
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: [20 Jul 2011] Abbott Medical Optics (AMO) STAR S4 IR Excimer Laser System Software, Versions 5.00 through 5.22 and Versions 5.00 through 5.30
  • Manufacturer
    Abbott Medical Optics (AMO)

Manufacturer

Abbott Medical Optics (AMO)