Events

Alerte De Sécurité sur Amvisc PLUS - PREPARATION viscoelastic STERILE - registration 10196150045 - Lots D090105D D100009A, D100011A, D100016A, D100016B, D100016C, D100026C, D100044D, D100060A, D100060B, D100080A, D100081A, D110015A, D110045A, D110046A, D110070A, D110071A, D110072A, D110091A, D110091A, 024028

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par BL INDÚSTRIA OTICA LTDA.

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
  • ID de l'événement
    1205
  • Date
    2012-11-29
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notes supplémentaires dans les données
    The company informs that this field action is in a global scope and that there was no receipt of any claim in Brazil. Further informs that this recall does not apply to cannulae with 8 digit lot numbers packed with the Amvisc Plus product; also does not apply to the viscoelastic contained in the glass syringes of the Amvisc Plus product. To date, no notifications have been identified in the NOTIVISA. UPDATE: The company updated the information on 1/30/2013 and added two more batches affected by the field action: D100016A and D090105D. For more information, please contact Customer Service at 08007026464, or e-mail: maria.iung@bausch.com
  • Cause
    Bausch + lomb, inc. recently identified that some disposable canisters (with a 4-digit batch number) supplied with the dvo amvisc plus are not fitting properly to the luer-lock in the sterile glass syringes of amvisc plus. disposable cannulae with 4-digit lot numbers may leak viscoelastic material or dislodge the syringe during injection. the immediate consequence of cannula detachment during intraocular use could involve damage to the intraocular tissue, which may or may not have far-reaching consequences, depending on the specific tissue involved and the nature of the injury.
  • Action
    Discontinue use of the affected lots of Amvisc Plus DVO immediately.

Device

Amvisc PLUS - PREPARATION viscoelastic STERILE - registration 10196150045 - Lots D090105D D100009...

Manufacturer

BL INDÚSTRIA OTICA LTDA