Events

Alerte De Sécurité sur Lenscare SH-System Monatslinsen monthly 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 4CARE GmbH.

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
    2013-11-20
  • 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_20131120a.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
    Safety alert over lenscare sh-system monatslinsen monthly contact lenses the department of health (dh) today (november 19) drew public attention to the recall of lenscare sh-system monatslinsen contact lenses because the surface of these lenses can get scratches during wearing and can even break. the dh, through its routine surveillance on medical devices, found that the united kingdom's medicines and healthcare products regulatory agency had posted a notice issued by a german manufacturer, 4care gmbh. according to the manufacturer, customer complaints for certain lot numbers of the products have increased recently. it was found that the surface of the lenses can get scratches during wearing and can even break. this may lead to foreign body sensation, blurred vision or eye irritation. the manufacturer advised users to stop using the products immediately. "the dh is following up with the manufacturer in germany to ascertain if the products have been distributed in hong kong. so far, the dh has not received any local reports of adverse events associated with the products," the spokesman said. "those customers who have purchased the said products should stop using them. they should consult health-care professionals for advice as soon as possible if they are either feeling unwell after using the products or in doubt," the spokesman added. the dh has informed public and private hospitals, relevant medical associations and optometrist associations about the issue. ends.

Device

Lenscare SH-System Monatslinsen monthly contact lenses
  • Modèle / numéro de série
  • Description du dispositif
    Press release: Safety alert over Lenscare SH-System Monatslinsen monthly contact lenses
  • Manufacturer
    4CARE GmbH

Manufacturer

4CARE GmbH
  • Source
    DH