Events

Alerte De Sécurité sur TECNIS 1-Piece Intraocular Lenses

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
    2016-09-02
  • Date de publication de l'événement
    2016-09-02
  • 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_20160902b.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 tecnis 1-piece intraocular lenses medical device manufacturer, abbott medical optics, has issued a medical device safety alert concerning its tecnis 1-piece intraocular lenses (iols). [model: zcb00; diopter 24.5; serial number: 4651021512]. the manufacturer has become aware of a small number of tecnis iols that may have been mislabeled during the manufacturing process. the manufacturer is initiating this action due to detection of an inspection equipment malfunction that resulted in lenses not being fully checked prior to release. it has been identified that this malfunction may result in the release of mislabeled iols. according to the manufacturer, use of a mislabeled iol could lead to potential unexpected postoperative refractive error and may result in a secondary surgical intervention. the likelihood of any impact to the patients is very low. product recall is on-going. according to the local supplier, the affected product is distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 2 september 2016.

Device

TECNIS 1-Piece Intraocular Lenses
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Abbott Medical Optics TECNIS 1-Piece Intraocular Lenses
  • Manufacturer
    Abbott Medical Optics

Manufacturer

Abbott Medical Optics