Events

Alerte De Sécurité sur Alcon AcrySof CACHET PHAKIC Lens

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

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
    2014-09-25
  • Date de publication de l'événement
    2014-09-24
  • 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_20140925.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: alcon acrysof cachet phakic lens the australia therapeutic goods administration (tga) posted a medical device safety alert concerning acrysof cachet phakic lens manufactured by alcon laboratories inc. the manufacturer is discontinuing the sale of the cachet phakic lens based on data analysis from an ongoing 10-year study to evaluate the safety of the cachet phakic lens in patients with myopia (near-sightedness) from -6.0 to -16.5 d vision correction. according to the manufacturer, the clinical data analysis indicates an increase in the number of cases of endothelial cell loss (ecl). in the clinical study, patients’ endothelial cell density (ecd) levels are monitored at 6 month intervals, as recommended by the current cachet phakic lens directions for use (dfu). to date, only 2.7% of the 1,323 cachet phakic lenses implanted in the clinical study were explanted due to ecl. for patients with the cachet phakic lenses already implanted, the manufacturer recommends adherence to the monitoring requirements described in the current dfu. adherence to these requirements by patients will help to timely identify significant ecl and determine the appropriate treatment plan. for details, please refer to the following tga website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2014-rn-01013-1 according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 24 september 2014.

Device

Alcon AcrySof CACHET PHAKIC Lens
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Alcon AcrySof CACHET PHAKIC Lens
  • Manufacturer
    Alcon Laboratories Inc

Manufacturer

Alcon Laboratories Inc