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 D.O.R.C. Dutch Opthalmic Research Center.

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 144 05 17 000
  • Event Initiated Date
    2017-05-28
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=11106
  • 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
    Dorc became aware that the use of the 1363.Dd vfi pack for silicone oil syringes in combination with certain batches of 10m1 prefilled glass syringes containing silicone oil (i.E. sil-1000-s and sil-5000-s with expiry dates as of 2017-12) could result in breaking of the finger flange of the glass syringe, leaving the contents of the syringe (silicone oil) untouched.

Device

VFI Pack for Silicone Oil syringes.
  • Model / Serial
    Description: VFI Pack for Silicone Oil syringes Article number: 1363.DD Batch Numbers: 140585, 160291, 170775, 1406103, 160390, 170806, 140630, 1604113, 170939, 140638, 160515, 171009, 140919, 160612, 1712140, 140973, 160786, 1712150, 141051, 160821, 1712168, 150301, 160931, 171218, 150473, 160937, 171260, 1505133, 160949, 180135, 150518, 161148, 180209, 150614, 161216, 1802100, 150778, 170120, 180370, 150820, 170272, 1804121, 150992, 170311, 1804148, 151079, 1704186, 1804149, 151108, 170473, 1804180, 151196, 170512, 1806149, 151227, 170599, 180628, 151248, 170628, 180745, 160167, 170704, 1808166, 160225, , 1707135
  • Product Description
    Retinal tamponade medium, postoperative
  • Manufacturer
    D.O.R.C. Dutch Opthalmic Research Center

Manufacturer

D.O.R.C. Dutch Opthalmic Research Center
  • Manufacturer Parent Company (2017)
    Oculus Holding B.V.
  • Manufacturers representative
    Albasar For Medical Supplies
  • Source
    SFDA