Events

Alerte De Sécurité sur Algerbrush- II and its accessories

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
    2016-11-28
  • Date de publication de l'événement
    2016-11-28
  • 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_20161128.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 algerbrush- ii and its accessories medical device manufacturer, bausch & lomb, has issued a medical device safety alert concerning algerbrush- ii and its accessories [product description (part number): 1) algerbrush-ii 0.5mm (e0815 a) ; 2) algerbrush-ii 1.0mm (e0815 b); 3) burr/chuck replaces 0.5mm (e0815 0.5); 4) burr/chuck replaces 1.0mm (e0815 1.0); 5) pterygium burr medium diamond (e0816 c)]. an internal investigation by the manufacturer found that the operating instructions packed with the product are missing or out of date. the manufacturer advises users that the algerbrush-ii can continue to be used following the updated sterilization instructions provided in the field safety notice. the new operating instructions now contain specific time and temperature for sterilization. failure to follow the new revised operating instruction can result in potential adverse events including eye infections. the manufacturer will send the updated operating instruction (rev.3 april 2012) to all affected customers. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 28 november 2016.

Device

Algerbrush- II and its accessories
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Algerbrush- II and its accessories
  • Manufacturer
    Bausch & Lomb

Manufacturer

Bausch & Lomb