Events

Recall of HYDROMAX acrylic hydrophobic lenses

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 MEDITEC.

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
    2008-03-21
  • 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-de-lots-de-lentilles-en-acrylique-hydrophobe-hydromax-de-la-societe-carl-zeiss-meditec
  • 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
    On March 21, 2008, the company CARL ZEISS MEDITEC withdrew from the market all the batches of the medical device called "HYDROMAX acrylic hydrophobic lenses" sterilized with ethylene oxide, following reports reporting the formation of micro-vacuoles or vacuoles opalescence / opacification (glistening) .. The company CARL ZEISS MEDITEC directly notified the recipients of the incriminated lots with the message attached (21/03/2008) (23 KB) validated by Afssaps. This information is addressed to directors and correspondents of materiovigilance for dissemination, where appropriate, to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

HYDROMAX acrylic hydrophobic lenses

Manufacturer

CARL ZEISS MEDITEC