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 Bausch & Lomb Inc.

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 051 12 12 000
  • Event Initiated Date
    2012-12-10
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=2714
  • 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
    Some 27g disposable cannulas manufactured by rhein medical, inc. provided with the amvisc or amvisc plus ovd are not properly engaging to the luer-lock on the amvisc and amvisc plus sterile glass syringes. the 27g disposable cannulas may leak viscoelastic material or detach from the syringe during injection. immediate consequences of cannula detachment during intraocular use could include damage to intraocular tissue.

Device

OVD, 27G disposable cannula Amvisc and Amvisc Plus devices
  • Model / Serial
    Model numbers 59051,59081,60081 Model numbers 59051L, 59081L, 60051L, 60081L The OVD containing recalled cannula was manufactured between February 2010 to August 2012 with expiry dates ranging from December 2001 to June 2015
  • Product Classification
    Ophthalmic Devices
  • Product Description
    OVD, Amvisc and Amvisc Plus devices
  • Manufacturer
    Bausch & Lomb Inc

Manufacturer

Bausch & Lomb Inc
  • Manufacturer Parent Company (2017)
    Bausch Health Cos., Inc.
  • Manufacturers representative
    Al-Faisaliah Medical System, Riyadh, (01) 2119948
  • Source
    SFDA