Events

Recall of ACR6D intraocular lenses pre-loaded injector PREMIER

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 CORNEAL.

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
    2005-03-09
  • 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-lentilles-intra-oculaires-pre-chargees-en-injecteur-de-la-societe-corneal
  • 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
    The Afssaps was informed on March 1, 2005 by CORNEAL of the withdrawal of the market on February 18, 2005 from all lots of the medical device called "ACR6D intraocular lenses pre-loaded injector PREMIER" following an increase in cases. endophthalmitis and / or delayed inflammatory reactions. The company has directly notified the health facilities concerned with the attached message (01/03/2005) (7 ko). This reminder concerns only France, the incidents described above have been reported only in France, to date. The competent European authorities are informed by Afssaps.

Device

ACR6D intraocular lenses pre-loaded injector PREMIER
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    CORNEAL

Manufacturer

CORNEAL
  • Source
    LAANSM