Events

Alerta De Seguridad para 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

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por BL INDÚSTRIA OTICA LTDA.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1205
  • Fecha
    2012-11-29
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    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
  • Causa
    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.
  • Acción
    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