Events

Alerte De Sécurité sur Proclear Toric Soft Hydrophilic Contact 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 Coopervision.

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
    2014-10-03
  • Date de publication de l'événement
    2014-10-03
  • 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_20141003.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: coopervision proclear toric soft hydrophilic contact lenses the australia therapeutic goods administration (tga) posted a medical device safety alert concerning proclear toric soft hydrophilic contact lenses manufactured by coopervision. the manufacturer's investigation of the complaints received have identified that a limited number of lots were manufactured with the cylinder axis outside the allowable specification. according to the manufacturer, there is no added medical risk to an incorrect axis lens use, since the patient will notice the blur and visual disturbance right away and report it to the practitioner. replacement of the lens with the proper power parameter in sphere and cylinder, and/or axis of astigmatism will alleviate the visual blur and disturbance. according to the local supplier, the affected products were not distributed in hong kong. for details, please refer to the following link:http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2014-rn-01039-1 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 03 october 2014.

Device

Proclear Toric Soft Hydrophilic Contact Lenses
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Coopervision Proclear Toric Soft Hydrophilic Contact Lenses
  • Manufacturer
    Coopervision

Manufacturer

Coopervision