Events

Alerta De Seguridad para Envista MX60 - Intraocular Lenses, Record: 80136060137 - Lots - all lots packed in acrylic bottle, regardless of the date of manufacture ..

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por BL Industria Otica Ltda; Bausch & Lomb Incorporated.

¿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
    1500
  • Fecha
    2015-01-22
  • 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 recommended that the intraocular lens should not be implanted with saline loss.
  • Causa
    The company identified the absence or reduction of saline solution in the primary packaging (acrylic bottle) that conditions the intraocular lens. this identification is only possible when the package is opened.
  • Acción
    The company BL Industria Otica Ltda., Requests to all the clients the return of the intraocular lens Envista MX60 packaged in packaged of acrylic bottle. The returned lenses will be replaced by lenses placed in the new plastic primary packaging which was approved by ANVISA on 7/23/2014. Inquiries, contact the company by e-mail sac@bausch.com or telephone 08007026464.

Device

Envista MX60 - Intraocular Lenses, Record: 80136060137 - Lots - all lots packed in acrylic bottle...

Manufacturer

BL Industria Otica Ltda; Bausch & Lomb Incorporated