Events

Safety Alert for Vitrectomy Cutter

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Abbott Medical Optics.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2017-04-21
  • Event Date Posted
    2017-04-21
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170421.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: abbott medical optics vitrectomy cutter medical device manufacturer, abbott medical optics (amo), has issued a medical device safety alert concerning its vitrectomy cutter [part number: ngp0025; lot numbers: ca06182]. the manufacturer has voluntarily initiated a recall of vitrectomy cutters because a possibility exists that, due to a packaging error, 20ga vitrectomy cutters may be found in a 25ga package and 25ga vitrectomy cutters may be found in a 20ga package. use of a vitrectomy cutter that is a different size than expected could lead to the need to alter the surgical technique, including conjunctival dissection, incision enlargement and sclera sutures. according to the manufacturer, two units of 20ga vitrectomy cutters in packaging labeled as 25ga the affected users are advised to stop using and remove from the inventory all affected product. they can continue to use all other lots not affected by this recall. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 21 april 2017.

Device

Vitrectomy Cutter
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Abbott Medical Optics Vitrectomy Cutter
  • Manufacturer
    Abbott Medical Optics

Manufacturer

Abbott Medical Optics