Events

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

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by ALCON LABORATÓRIOS DO BRASIL LTDA.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    447
  • Date
    2002-04-01
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the 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.
  • Reason
    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.
  • Action
    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