Events

Alerte De Sécurité sur Healon Ophthalmic Viscoelastic Devices

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
    2017-04-19
  • Date de publication de l'événement
    2017-04-19
  • 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_20170419.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 healon ophthalmic viscoelastic devices medical device manufacturer, abbott medical optics (amo), has issued a medical device safety alert concerning its healon ophthalmic viscoelastic devices (ovds) [model: healvon (0.85ml), lot number: ub32573; healvon gv (0.85ml); lot number: ub32576]. according to the manufacturer, certain healon ovd solutions in the affected lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process. use of ovd solutions with glass particles could potentially lead to intraocular injury. the affected users are advised to stop using and remove from the inventory all affected ovd lots. they can continue to use all other lots not affected by this recall. 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 19 april 2017.

Device

Healon Ophthalmic Viscoelastic Devices
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Abbott Medical Optics Healon Ophthalmic Viscoelastic Devices
  • Manufacturer
    Abbott Medical Optics

Manufacturer

Abbott Medical Optics