Events

Alerte De Sécurité sur MeniCare Soft 70ML

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Menicon Ltd..

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
    2018-01-16
  • Date de publication de l'événement
    2018-01-16
  • 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_20180116.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
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: menicon menicare soft 70ml the medicines and healthcare products regulatory agency (mhra), united kingdom has posted a medical device safety alert concerning menicare soft 70ml, manufactured by menicon ltd. [affected lot numbers - (box): mp17288 and mp17350; (bottle): 703061]. according to the manufacturer, process simulation (media fill testing) in manufacturing process line was conducted and the result was failed. in regard to the manufacturing line, the manufacturer confirmed the suitability of sterility guarantee on a regular basis. as the result of last validation was passed, the manufacturer confirmed that there is no influence on the sterility of products produced until last validation. furthermore, no reports of damage to health have been received. the sterility tests performed for each manufactured lot were passed, so the possibility of any damage to health is thought to be extremely low. the manufacturer has decided to recall products manufactured after the validation as it is difficult to guarantee sterility completely. the users are advised to take the following actions:- identify and quarantine the device(s) based on the affected lot numbers if they already have used menicare soft of the affected lot numbers, the affected product should be replaced with new one. if they have symptoms like red eye, eye pain or any discomfort, they should remove lenses and contact their eye care professional. for details, please refer to the mhra website: https://www.Gov.Uk/drug-device-alerts/field-safety-notice-8-to-12-january-2018 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 16 january 2018.

Device

MeniCare Soft 70ML
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Menicon MeniCare Soft 70ML
  • Manufacturer
    Menicon Ltd.

Manufacturer

Menicon Ltd.