Events

Recall of Amo Prestige OPO40 tubing packs

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.

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
    2004-04-19
  • 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-de-packs-tubulures-opo40-utilisees-avec-le-systeme-de-phacoemulsification-amo-prestige
  • 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
    Afssaps has been informed of a recall of Amo Prestige OPO40 tubing packs used with the AMO Prestige phacoemulsification system. This recall was made by the company AMO March 31, 2004 following a problem of sealing of the outer packaging. Health facilities concerned by the recall in France received the enclosed letter (31/03/2004) (38 KB). The other European Competent Authorities have been informed of this measure by the manufacturer.

Device

Amo Prestige OPO40 tubing packs
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    AMO

Manufacturer

AMO