Events

Recall of COMPLETE® MoisturePLUS

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
    2007-06-01
  • 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-tous-les-lots-de-solution-complete-moisture-plus-amo
  • 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
    AMO voluntarily recalls COMPLETE® MoisturePLUS maintenance solutions. This recall follows a report by the American Center for Disease Control and Prevention (CDC), where the risk of Acanthamoeba keratitis (current water amoeba) for users of this solution is estimated to be seven times higher (2 cases per year). million) for non-users. Although no contamination of the product has been established to date, and the risk of infection is very low, AMO, as a precautionary measure, recommends to patients to change maintenance solution while waiting for further information. This recall does not apply to other AMO products. The competent authorities have been informed by the company. This message is intended for pharmacists, ophthalmologists (01/06/2007) (110 ko) and opticians (01/06/2007) (113 ko).

Device

COMPLETE® MoisturePLUS

Manufacturer

AMO