Events

Recall of VTRAX II, OPHTHALMIC VISCOSURGICAL DEVICE (3% Sodium Hyaluronate), 0.65 ml -product viscoelastic Vitrax II-

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 AMO France.

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
    2009-11-05
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/rappel-des-lots-du-dispositif-medical-vtrax-ii-ophtalmic-viscosurgical-device-3-sodium-hyaluronate-0-65-ml-produit-viscoelastique-vitrax-ii-amo-france
  • 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 30/10/09, the company AMO France withdrew from the market the lots mentioned in the appendix of the recall letter of reference VT 465 of the medical device called VTRAX II, OPHTHALMIC VISCOSURGICAL DEVICE (3% Sodium Hyaluronate), 0.65 ml -product viscoelastic Vitrax II-manufactured by AMO Ireland. Indeed, during routine stability testing, the pH of the product in some syringes is out of specification and exceeds the acceptance range of 6.8 to 7.5 established by AMO as well as the acceptance range of 6.8 to 7.6 stipulated for these devices by the international standard ISO 15798: 2001 - Ophthalmic implants - Viscoelastic ophthalmic devices (DOV). The results found were nevertheless not more than 8.2. The literature reports a risk of damage to endothelial cells if the pH exceeds 8.5. The company AMO France has directly notified the recipients of the incriminated lots with the attached message (05/11/2009) (26 KB) validated by Afssaps. This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

VTRAX II, OPHTHALMIC VISCOSURGICAL DEVICE (3% Sodium Hyaluronate), 0.65 ml -product viscoelastic ...
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    AMO France

Manufacturer

AMO France