Events

Recall of Perspective Hitech intraocular 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 NMM.

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
    2006-01-10
  • 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-lots-de-lentilles-intra-oculaires-de-la-societe-pht-industries
  • 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 company NMM (buyer of the company PHT INDUSTRIES) withdraws from the market all batches of the medical device called "Perspective Hitech intraocular lenses" references PM601, A60P, T65, AP12, AP13, SOF6, HQ203 marked CE 0434 following several complaints mainly focused on refractive errors .. The company has directly notified the recipients concerned with the message attached (10/01/2006) (19 KB) validated by the Afssaps .. The T65 implants manufactured by NMM and marked CE 0120 are not concerned by this reminder. This information is addressed to the directors of health establishments and the local correspondents of materiovigilance for diffusion, if necessary with the services concerned .. This reminder relates only to France.

Device

Perspective Hitech intraocular lenses
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    NMM

Manufacturer

NMM
  • Source
    LAANSM