Events

Safety Alert for Envista MX60 - Intraocular Lenses, Record: 80136060137 - Lots - all lots packed in acrylic bottle, regardless of the date of manufacture ..

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by BL Industria Otica Ltda; Bausch & Lomb Incorporated.

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
    1500
  • Date
    2015-01-22
  • 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
    The company recommended that the intraocular lens should not be implanted with saline loss.
  • Reason
    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.
  • Action
    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