Alerte De Sécurité sur contact lens solutions

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

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
  • Pays de l'événement
  • Source de l'événement
  • 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
    Dh and customs keep close watch on recall of contact lens solutions the following is issued jointly by department of health and customs and excise department: representatives of the department of health (dh) and the customs and excise department met today (november 23) to discuss the latest situation regarding the voluntary recall of ten lots of four types of contact lens solutions manufactured by advanced medical optics, inc. a telephone hotline 2125 1133 has been set up by dh to provide health advice to the public. contact lens users using the concerned solutions with symptoms of infection or discomfort are also urged to call the hotline. it will be operated during office hours. according to the information provided by the manufacturer, testing of the concerned solutions produced at its manufacturing plant in the mainland indicated microbial contamination. a dh spokesman said: “the centre for health protection (chp) is liaising with local ophthalmologists, optometrists and hospital authority for finding suspicious cases for necessary investigations.” the customs and excise department is monitoring the recall process of affected lots of concerned contact lens solutions and will enhance surveillance by taking samples of the solutions from the market for testing. to this end, dh's public health laboratory will provide necessary technical support. meanwhile, 20 samples of the line of products produced in the affected manufacturing plant bought by dh from the local market are being tested for sterility. results are expected to be available in 3-weeks' time. dh appealed contact lens users to stop using solutions of the affected lots. they should consult their doctors in case of discomfort or infection and may also call the manufacturer's hotlines at 2401 5811/ 2 in case of queries. contact lens users are reminded to observe good hygiene in handling the lens, solutions and utensils to prevent contact lens associated infection. details can be found in chp's website ( http://www.Chp.Gov.Hk/ ) under the consumer goods safety ordinance, it is an offence to supply, manufacture or import into hong kong consumer goods unless the goods comply with the general safety requirement for consumer goods. the maximum penalty for the offence is a fine of $100 000 and an imprisonment for one year on first conviction, and $500 000 and two years' imprisonment on subsequent conviction. for complaints regarding unsafe consumer goods, consumers can contact the consumer protection and prosecution bureau, customs and excise department on the 11th floor, north point government office, 333 java road, north point or call the customs hotline at 2545 6182. ends/thursday, november 23, 2006 nnnn.


  • Modèle / numéro de série
  • Description du dispositif
    Press release: DH and Customs Keep Close Watch on Recall of Contact Lens Solutions
  • Manufacturer