Events

Alerte De Sécurité sur ACUVUE®OASYS® with HYDRACLEAR® Plus 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 Johnson & Johnson Vision Care.

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
    2012-01-10
  • 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_20120111.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 selected lots of contact lenses the department of health (dh) today (january 10) drew public attention to the recall of three lots of contact lenses - acuvue®oasys® with hydraclear® plus contact lenses - because the affected products were found to have higher than expected levels of a diluting agent which could affect lens performance due to reduced wettability. a dh spokesman revealed that the department, through its routine surveillance on medical devices, found that the united kingdom's medicines and healthcare products regulatory agency had posted a recall notice issued by the manufacturer, johnson & johnson vision care. according to the manufacturer, the problem was due to an isolated interruption in the lens rinsing process on one manufacturing line and the cause has already been rectified. the manufacturer reported no consumer complaints or adverse events so far, and advised that while wearers of the affected lenses may experience some eye discomfort or eye redness upon lens insertion, long-term health consequences are highly unlikely. "the dh has immediately contacted the product's local supplier and found that the affected lots have not been distributed in hong kong. although the three lots under recall are not distributed in hong kong and we have no record of related adverse events here, the fact that there may be occasional users in the territory who have somehow obtained the affected products from abroad justify a public alert," the spokesman added. details of the affected products (8.8 base curve) are listed below. consumers are advised to check the printed lot number reading from left to right on the outer package and on each individual contact lens container to identify the affected products. lot number power l001rj5 -2.00d l001rj8 -2.75d l001rj9 -3.00d "those customers who have used the said products and are either feeling unwell or in doubt should consult their healthcare professionals for advice as soon as possible." the dh has informed public and private hospitals, relevant medical associations and optometrist associations about the issue. ends.

Device

ACUVUE®OASYS® with HYDRACLEAR® Plus Contact Lenses
  • Modèle / numéro de série
  • Description du dispositif
    Press release: Recall of selected lots of ACUVUE® OASYS® with HYDRACLEAR® Plus Contact Lenses
  • Manufacturer
    Johnson & Johnson Vision Care

Manufacturer

Johnson & Johnson Vision Care