Events

Recall of Intraocular lens injectors A6

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 CARL ZEISS MEDITECH.

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
    2008-10-21
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-d-un-lot-d-injecteurs-de-lentille-intra-oculaire-a6-par-la-societe-carl-zeiss-meditech
  • 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
    The company CARL ZEISS MEDITECH, informed, on 10/10/2008, the users of intraocular lens injectors A6 of the withdrawal of the devices of lot 08.238. The users concerned, in France, received the attached mail (21/10/2008) (25 KB). In agreement with Afssaps, the company CARL ZEISS MEDITECH distributed on 17/10/2008 the additional information attached (21/10/2008) (13 ko) relating to the follow-up of the patients concerned. The competent European authorities have been informed of this measure by the manufacturer. This information is addressed to the directors of health establishments and local correspondents of materiovigilance for diffusion to the concerned services.

Device

Intraocular lens injectors A6

Manufacturer

CARL ZEISS MEDITECH