Events

Alerte De Sécurité sur 1 Day Acuvue TruEye

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.

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
    2010-08-20
  • 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/press_20100823.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
    Contact lens problems in response to media enquiries, a spokesman for the department of health (dh) said information provided by johnson & johnson (hk) limited indicated that the problem of its 1 day acuvue trueye which led to a recall of 16 batches of the product was caused by failure to remove a diluent during the rinsing process. according to johnson & johnson,the affected lots may contain lenses with trace amount of diluent agent that is intended to be extracted from the lens during the rinsing process. due to a mechanical failure in the rinsing process this extraction was not complete. this diluent agent is an intended part of the 1day acuvue trueye formulation and therefore is not considered a contaminant. in relation to the recall, the spokesman added that johnson & johnson had been asked to deploy more staff to man its enquiry hotline and speed up recall and product replacement. the spokesman said: "dh's investigation continues and the recall will be closely monitored." 20 august 2010.

Device

1 Day Acuvue TruEye
  • Modèle / numéro de série
  • Description du dispositif
    Press release: Contact lens problems
  • Manufacturer
    Johnson & Johnson

Manufacturer

Johnson & Johnson