Alerte De Sécurité sur 1-Day Acuvue Moist Brand Contact Lenses and Acuvue Advance Brand Contact Lenses with Hydraclear

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
    2013-01-15
  • Pays de l'événement
  • Source de l'événement
    DH
  • URL de la source de l'événement
  • 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 two brands of acuvue contact lenses the department of health (dh) today (january 15) drew public attention to the recall of selected lots of 1-day acuvue moist brand contact lenses and acuvue advance brand contact lenses with hydraclear as the affected products might have incomplete package sealing which might compromise the sterility of the contact lenses. the dh, through its routine surveillance on medical device safety information, found that the united kingdom's medicines and healthcare products regulatory agency (mhra) had posted a recall notice issued by the manufacturer, johnson & johnson vision care. according to the manufacturer, the problem came to light during an internal quality review which had discovered the potential for a limited number of contact lens packages to be incompletely sealed. "an incomplete seal may compromise contact lens sterility, which may pose the risk of an eye infection," a dh spokesman explained. "the dh has immediately contacted the products' local supplier and found that apart from the lots listed in the mhra's website, there are other affected lots being recalled in other countries. however, none of the known affected lots have been distributed in hong kong. although the 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 via the internet or from abroad justifies a public alert," the spokesman added. according to the manufacturer, there are no reports of adverse events so far. the dh will continue to follow up with the local supplier to ascertain the scope of the recall and the root cause of the problem. details of the affected products are listed below. consumers are advised to check all the digits of 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. 1-day acuvue moist brand contact lenses (8.5 base curve) lot number power 2054890422 +2.25d 2054890521 +2.25d 2054895620 +2.25d 1536500620 -3.75d 2138800422 -4.75d acuvue advance brand contact lenses with hydraclear lot number power b00djpq -7.00d(8.3 base curve) b00dmhz -6.00d (8.3 base curve) b00dmjp +4.00d (8.7 base curve) "those customers who have used the said products and are feeling unwell or are in doubt should consult their healthcare professionals for advice as soon as possible," the spokesman said. the dh has informed public and private hospitals, relevant medical associations and optometrist associations about the issue. ends.

Device

  • Modèle / numéro de série
  • Description du dispositif
    Press release: Recall of selected lots of two brands of Acuvue contact lenses
  • Manufacturer

Manufacturer