Events

Recall of FreshLook Colors Sapphire Blue contact 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 Cibavision.

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
    2010-08-13
  • 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-de-contact-freshlook-colors-sapphire-blue-et-violet-cibavision-retrait-de-lots
  • 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    On 12/08/2010, the company Cibavision SAS has withdrawn lots 304980, 312944 from the medical device called "FreshLook Colors Sapphire Blue contact lenses" and lot 302592 from the medical device named "FreshLook Colors Violet" contact lenses, following the discovery of lens boxes that may contain lenses of power -5.50 D instead of lenses of power + 2; 50 D, as indicated on the packaging of the product. The company Cibavision SAS has directly notified the recipients of the incriminated lots with the message attached (13/08/2010) (100 KB) validated by Afssaps.This information is for opticians and distributors of these lenses . The competent European authorities concerned are informed of this measure by CibaVision.

Device

FreshLook Colors Sapphire Blue contact lenses
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Cibavision

Manufacturer

Cibavision