Events

Alerte De Sécurité sur Avaira and BioComfort XO 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
    2011-11-16
  • 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/press_20111116.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
    Press release
  • Cause
    Recall of avaira and biocomfort xo contact lenses the department of health (dh) today (november 16) endorsed the recall of avaira and biocomfort xo contact lenses in hong kong as the product’s manufacturer in the united states, coopervision, has expanded its global recall of the avaira brand product line of contact lenses announced in august this year. a dh spokesman said the product’s local distributor, coopervision hong kong revealed that the lenses are being recalled because of the presence of silicone oil residue which may cause hazy vision or discomfort, severe eye pain or even eye injuries requiring medical treatment. the spokesman said that coopervision had recalled its avaira toric and biocomfort xo toric contact lenses in august this year, following complaints of discomfort and/or blurred vision from consumers. he further explained that in view of possible consumer safety concern and to avoid market confusion, a total recall of avaira and biocomfort xo contact lenses in hong kong is a prudent measure. dh will alert the hospital authority, private hospitals, relevant healthcare institutions, medical and optometrists associations about the matter. the company has also set up a hotline at 3718 0688 to answer enquiries. "members of the public should cease using the product if they feel unwell, and consult their healthcare providers. dh will continue the investigation and closely monitor the recall." ends/ wednesday, november 16, 2011.

Device

Avaira and BioComfort XO contact lenses
  • Modèle / numéro de série
  • Classification du dispositif
    Ophthalmic Devices
  • Description du dispositif
    Press release: Recall of Avaira and BioComfort XO contact lense
  • Manufacturer
    CooperVision

Manufacturer

CooperVision