Alerte De Sécurité sur Avaira Toric daily 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
  • Pays de l'événement
  • Source de l'événement
  • URL de la source de l'événement
  • 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
    Press release
  • Cause
    Suspend use of avaira toric daily contact lenses advisable the department of health (dh) today (august 20) advises consumers to suspend use of avaira toric daily wear contact lens, pending dh's investigation. this is because the medical device's us manufacturer, coopervision is already embarking on recall of specific lots of the lens voluntarily, both in the states and also abroad in australia, canada, germany, italy and spain, amongst others, following complaints of discomfort and/or blurred vision from consumers. the appeal is made after dh has assessed into the situation with the information provided by the manufacturer's greater china regulatory affairs office, which also revealed that the affected products have been distributed in hong kong. "dh is being told that, working with the fda, the us manufacturer reckons the complaints were likely due to transient swelling of the surface layer of the cornea. in turn, this oedema could have been brought about by a small amount of residues on the lens," a dh spokesman quotes. "although the number of complaint reports is small, the regulatory affairs office reports that the us manufacturer deems its recalls both in the us and overseas to be in the best interests of its customers," the spokesman adds. the spokesman confirms that thus far, dh has not received any adverse reports arising from the use of the device. "however, given that the notifying regulatory affairs office cannot provide dh with adequate information on the incriminated lots and in view of possible consumer safety concern, we consider it prudent to advise members of the public to stop using the product for the moment, pending our investigation finding," the spokesman explains the rationale for dh's management. the spokesman urges all healthcare providers and local traders who have the affected product in hand to suspend supply temporarily. in addition, they should also report suspected adverse incidents to dh. "members of the public should consult their healthcare providers when in doubt and in particular, if they feel unwell after having used the product. the manufacturer also provides a hotline 3718 0602, 9am to 5pm, monday to friday for answering public enquiry," the spokesman remarks. ends/ sat, 20 aug 2011.


  • Modèle / numéro de série
  • Classification du dispositif
  • Description du dispositif
    Press release: Suspend use of Avaira Toric daily contact lenses advisable
  • Manufacturer