Events

Recall of NEWLIFE;VIVARTE PRESBYOPIC;GBR;VIVARTE MYOPIC

According to L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), this recall involved a device in France that was produced by IOLTECH.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Date
    2007-01-02
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/lentilles-intra-oculaires-newlife-vivarte-presbyopic-gbr-vivarte-myopic-de-ioltech
  • Notes / Alerts
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 recall data from the U.S. and France.
  • Extra notes in the data
  • Action
    In addition to the message of 13/03/2006 and in agreement with Afssaps, the company Ioltech informed on 28/12/2006 the users of intraocular lenses of anterior chamber for the correction of presbyopia or myopia NEWLIFE / VIVARTE PRESBYOPIC / GBR / VIVARTE MYOPIC of a reminder and a follow-up recommendation for implanted patients. The health facilities concerned in France have received the attached letter (02/01/2007) (36 KB) to the attention of the directors of health establishments and local correspondents of materiovigilance, for distribution to the ophthalmic services. The other competent European authorities have been informed of this measure by Afssaps. Read too. Temporary marketing cessation of Newlife intraocular lenses - IOLTEC. (13/03/06)

Device

NEWLIFE;VIVARTE PRESBYOPIC;GBR;VIVARTE MYOPIC
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    IOLTECH

Manufacturer

IOLTECH
  • Source
    LAANSM