Events

Alerte De Sécurité sur Stellaris Elite Single Port Vitrectomy Cutters

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
    2018-08-07
  • Date de publication de l'événement
    2018-08-07
  • 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_20180807.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 stellaris elite single port vitrectomy cutters medical device manufacturer, bausch & lomb, has issued a medical device safety alert concerning its stellaris elite single port vitrectomy. the manufacturer is conducting a voluntary recall of 29 lots of the affected products in gauge sizes 20, 23 and 25 after receiving a limited number of customer reports of the back cap separating from the body of the cutter during surgery. no reports of patient injury have been reported as a result of these incident. according to the manufacturer, the vitrectomy cutter handle is assembled by press-fitting the back cap to the vitrectomy cutter body. bonding agent is then applied to the handle seam where it wicks into the assembly interface. during operation the seal joint can be exposed to a maximum internal pulse pressure of 42 psi. probable cause for the failure has been identified as insufficient bonding agent between vitrectomy cutter back cap and body. quality change request was initiated to further investigate and improvements to the bonding process have been implemented during production. product replacement is on-going. according to the local supplier, the affected products has been imported in hong kong. the impacted lots, however, are not released to market and are held in its warehouse. they are identified as below: 20ga 7.5k pneumatic vit cutter [part number: bl5626; lot number: v9400] 23g post elite w mf 6/bx [part number: se5423mv; lot number: w1721, w0147] 23g post elite w wf 6/bx [part number: se5423wv; lot number: w0148] 25g post elite w wf 6/bx [ part number: se5425wv; lot number: w0157] 23g combo elite w mf 6/bx [part number: se5523mv; lot number: w0783] 25g combo elite w mf 6/bx [part number: se5525mv; lot number: w0787] if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 7 august 2018.

Device

Stellaris Elite Single Port Vitrectomy Cutters
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Rupture of Membranes Tests
  • Manufacturer
    Bausch & Lomb

Manufacturer

Bausch & Lomb