Events

Alerta De Seguridad para 10 cc silicone oil injection / extrusion line for use with ACCURUS. All lot numbers beginning with six (6) or nine (9)

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por ALCON LABORATÓRIOS DO BRASIL 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
    447
  • Fecha
    2002-04-01
  • 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
    02/03/2002 -The Silicone Oil Injection / Extrusion line is marketed in Brazil under the registration number 10002390065, published in DOU 12/24/1996 (lines for Ophthalmic equipment) ANVISA is accompanied by the company's action in all steps to ensure the sanitary safety of the products in question, keeping all the necessary clarifications up to date. 08/04/2002 - ANVISA / UTVIG requested the company to send a copy of the signed letters of receipt of the notifications issued to the doctors / surgeons where the discontinuation of the use of the product was requested. 06/18/2002 - The company informs that of the total of 116 doctors / surgeons who have received some unit of the lots of SILICONE OIL INJECTION / EXTRUSION LINE 111 already sent the signed notifications of recollection, and that the rest is still 05 were not returned because they are doctors / surgeons located in regions that are difficult to access. 06/08/2002 - The company informs that the process of picking up the Silicon Oil Injection / Extrusion Line was closed on 07/31/2002, and that all legal procedures in the collection process were complied with.
  • Causa
    Possibility of partial drilling of the line plunger. a quietly perforated plunger can act as a single-way valve, restricting the ventilation of the pressurized air, which can result in a delay in stopping the flow of the fluid.
  • Acción
    ALCON initiated voluntary recall by letter dated March 27, 2002, of batches of products whose numbers start with six (6) or nine (9), and requiring surgeons to discontinue use of the product and to return the remaining stock to the Company / ALCON LABORATORIES DO BRASIL LTDA. It also informs that 1,212 units of the product whose lot numbers are affected have been placed on the market. For more information, please contact Lygia Casella Piazza - Responsible Pharmacy, at (11) 3732-4103 or (11) 3732-4119.

Device

10 cc silicone oil injection / extrusion line for use with ACCURUS. All lot numbers beginning wit...

Manufacturer

ALCON LABORATÓRIOS DO BRASIL LTDA
  • Source
    ANVSANVISA