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
    2010-08-19
  • 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_20100820.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
    Voluntary recall of single-use contact lenses the department of health (dh) was notified by johnson & johnson (hk) limited today (august 19) that a voluntary recall of 16 batches of contact lens 1 day acuvue trueye is underway due to potential eye irritation or discomfort as a result of using the product. a dh spokesman said the affected batch was manufactured in ireland with lot numbers - 492237, 492238, 492241, 492245, 492250, 492251, 492252, 492254, 492268, 492280, 492281, 492282, 492283, 492287, 492288 and 492289. these numbers are the first six digits of the lot number printed at the side of the product box. according to johnson & johnson, the recall followed complaints regarding "unusual stinging or pain upon inserting of lens" reported in japan, which included stinging, ocular pain, redness and irritation. the investigation of the manufacturer so far showed that there was a problem in one portion of the lens rinsing process on a particular manufacturing line during a certain period of time. in hong kong, there has so far been no reported adverse events arising from use of the affected batches. according to the local supplier, about 3,715 boxes of the affected batches have been shipped out to optical outlets. the spokesman advised that members of the public should stop using the affected product and contact the company at their hotline, 2963 6799, for recall and product replacement. the hotline will operate from august 20 until september 22, daily between 9am and 6pm. the recall details can also be accessed at the website: www.Acuvue.Com.Hk. those who feel unwell after using the product should seek advice from their healthcare professionals. meanwhile, the dh has informed both public and private hospitals, relevant medical associations and optometrist associations about the issue. the recall will be closely monitored. ends/thursday, august 19, 2010.

Device

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

Manufacturer

Johnson & Johnson