Events

Recall of AQUALARM Unidose

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 CHAUVIN BAUSCH and LOMB.

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
    2008-01-31
  • 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-lot-du-collyre-aqualarm-unidose-du-laboratoire-chauvin-bausch-et-lomb
  • 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 January 29, 2008, the laboratory CHAUVIN BAUSCH and LOMB removed from the market lot 573427 of the medical device called eye drops AQUALARM Unidose following a technical problem observed on the filling line of the product. The laboratory CHAUVIN BAUSCH and LOMB directly notified the recipients of the incriminated lot with the message attached (29/01/2008) (35 KB) validated by Afssaps. This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned. This recall only concerns France.

Device

AQUALARM Unidose

Manufacturer

CHAUVIN BAUSCH and LOMB