Alerta De Seguridad para Intraocular Lens Mediphacos - Product Composition: Hydroxyethylmethacrylate Polymethylmethacrylate or Copolymer

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.

The Director of the Collegiate Board of the National Sanitary Surveillance Agency, in the use of the attribution conferred by Administrative Rule 327 of May 16, 2003, with clause I of art. 2, of the Resolution of the Collegiate Board of Directors - RDC No. 1, of October 1, 1999, considering paragraph 3 of art. 111 of the Internal Regulations approved by Administrative Rule no. 593 of August 25, 2000, republished on December 22, 2000; considering Art.10, items XV and XXIX, of Law no. 6.437, of August 20, 1977; considering the arts. 7, 57 and 60 of Law 6,360 / 76 of September 23, 1976; the arts. 8, 94, 116 and 120 of Decree No. 79.094 / 77 of January 5, 1977; considering RDC-185/01 of October 22, 2001; considering the ATA of the Joint Inspection ANVISA / VISA-MG, held in the period from June 30 to July 4 in the company; considering, NOTIFICATION No. 34/2003, of July 04, 2003, of the State Department of Health of the State of Minas Gerais, resolves: Article 1 To determine, as a precautionary measure, throughout the national territory, the prohibition and suspension of the sale of the product INTRAOCULAR LENS (Intraocular Lens Mediphacos), registration nº 10161000001, manufactured by the company MEDIPHACOS LTDA, located at Rua Mestre Luiz, nº 31-43, Belo Horizonte / MG, for marketing the product with labeling / packaging in disagreement the one presented in the registration process granted by ANVISA / MS. Article 2 The above mentioned company is hereby intimated in this act to present, wanting, its defense or impugnation, which will have the period of 15 (fifteen) days. Article 3 This Resolution shall enter into force on the date of its publication. CLAUDIO MAIEROVITCH PESSANHA HENRIQUES