Events

translation missing: fr.activerecord.attributes.event.titles.recall_field_safety_notice

Selon Saudi Food & Drug Authority, ce/cet/cette translation missing: fr.activerecord.attributes.event.types.recall_field_safety_notice concerne un dispositif en/au/aux/à Saudi Arabia qui a été fabriqué par Johnson & Johnson Vision Care.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Recall / Field Safety Notice
  • ID de l'événement
    mdprc 003 11 17 000
  • Date de mise en oeuvre de l'événement
    2017-11-02
  • Pays de l'événement
    Saudi Arabia
  • Source de l'événement
    SFDA
  • URL de la source de l'événement
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=11703
  • Notes / Alertes
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • Notes supplémentaires dans les données
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Cause
    A limited number of confirmed reports has been received by the manufacturer of a lens being ‘off power’ which the consumer may recognize as not accurately correcting the vision in one eye (some distortion or blurriness). upon investigation, it was determined that inserts within the mold used for manufacturing were damaged when making the front and back curve molds of the contact lens. johnson & johnson vision care has implemented improved inspection techniques for the identification of damaged inserts within the molds. not all lenses in these lots are affected and there is no significant health risk related to this issue.

Device

ACUVUE® OASYS® Brand Contact Lenses for ASTIGMATISM with HYDRACLEAR® PLUS
  • Modèle / numéro de série
    Product Specification: BC 8.6, -6.00D/-1.75D/170 Lot Number : B00GW4Z
  • Description du dispositif
    Contact Lenses, Vision Corrective
  • Manufacturer
    Johnson & Johnson Vision Care

Manufacturer

Johnson & Johnson Vision Care
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Représentant du fabricant
    Allied Medical International
  • Source
    SFDA