Events

Safety Alert for Acrysof Cachet Phakic (Intraocular Lens). Anvisa Registry n ° 80147540167. Models at risk: L12500, L13000, L13500 and L14000.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Novartis Biociências; Alcon Laboratories, Inc..

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
    1443
  • Date
    2014-10-23
  • 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 analysis of the clinical data performed by the company indicated an increase in the number of cases of endothelial loss (ECL) among patients with severe myopia. None of the study patients had permanent loss of vision. See details in the Safety Communication disclosed by the company, available at http://portal.anvisa.gov.br/wps/wcm/connect/be33848045efe1f4a03ba47ffa9843d8/Communicado+de+Seguran%C3%A7a.PDF?MOD=AJPERES.
  • Reason
    Increased endothelial loss (ecl) among patients with severe myopia.
  • Action
    The company is discontinuing the commercialization of the product. Patients with implanted Cachet Phakic lenses should continue to be monitored and evaluated constantly as described in the current Directions for Use of the product.

Device

Acrysof Cachet Phakic (Intraocular Lens). Anvisa Registry n ° 80147540167. Models at risk: L12500...

Manufacturer

Novartis Biociências; Alcon Laboratories, Inc.
  • Manufacturer Parent Company (2017)
    Novartis Ag
  • Source
    ANVSANVISA