Events

Alerte De Sécurité sur Disposable cannulas provided with Amvisc and Amvisc Plus Sodium Hyaluronate

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

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
    2012-11-16
  • Date de publication de l'événement
    2012-11-16
  • 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_20121116.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: bausch & lomb disposable cannulas provided with amvisc and amvisc plus sodium hyaluronate medical device manufacturer, bausch & lomb, inc., has initiated a voluntary product recall concerning disposable cannulas with 4-digit lots numbers provided with amvisc and amvisc plus. bausch & lomb, inc. recently identified that some disposable cannulas (with 4-digit lot numbers) provided with the amvisc or amvisc plus ophthalmic viscosurgical device (ovd) are not properly engaging to the luer-lock on the amvisc and amvisc plus sterile glass syringes. the disposable cannulas with 4-digit lot numbers may leak viscoelastic material or detach from the syringe during injection. in rare incidences, detachment has resulted in serious patient injury. this recall is limited to cannulas with 4-digit lot numbers pre-packaged with some amvisc and amvisc plus sodium hyaluronate in sterile glass syringes. it does not include cannulas with 8-digit lot numbers pre-packaged with some amvisc and amvisc plus ovd, nor does it include the amvisc or amvisc plus ovd in the glass syringes themselves. the manufacturer advised the users to discontinue the use of the affected products immediately. the affected products should continue to be refrigerated, but placed in quarantine. according to the local supplier, the affected devices were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 16 november 2012.

Device

Disposable cannulas provided with Amvisc and Amvisc Plus Sodium Hyaluronate
  • Modèle / numéro de série
  • Classification du dispositif
    Ophthalmic Devices
  • Description du dispositif
    Medical Device Safety Alert: Bausch & Lomb Disposable cannulas provided with Amvisc and Amvisc Plus Sodium Hyaluronate
  • Manufacturer
    Bausch & Lomb

Manufacturer

Bausch & Lomb