Events

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

According to Saudi Food & Drug Authority, this translation missing: en.activerecord.attributes.event.types.recall_field_safety_notice involved a device in Saudi Arabia that was produced by Johnson & Johnson Vision Care.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Recall / Field Safety Notice
  • Event ID
    mdprc 003 11 17 000
  • Event Initiated Date
    2017-11-02
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=11703
  • Notes / Alerts
    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.
  • Extra notes in the data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    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
  • Model / Serial
    Product Specification: BC 8.6, -6.00D/-1.75D/170 Lot Number : B00GW4Z
  • Product Description
    Contact Lenses, Vision Corrective
  • Manufacturer
    Johnson & Johnson Vision Care

Manufacturer

Johnson & Johnson Vision Care
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Manufacturers representative
    Allied Medical International
  • Source
    SFDA