Events

Safety Alert for Healon Ophthalmic Viscoelastic Devices

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
    2017-04-19
  • Event Date Posted
    2017-04-19
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170419.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 healon ophthalmic viscoelastic devices medical device manufacturer, abbott medical optics (amo), has issued a medical device safety alert concerning its healon ophthalmic viscoelastic devices (ovds) [model: healvon (0.85ml), lot number: ub32573; healvon gv (0.85ml); lot number: ub32576]. according to the manufacturer, certain healon ovd solutions in the affected lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process. use of ovd solutions with glass particles could potentially lead to intraocular injury. the affected users are advised to stop using and remove from the inventory all affected ovd lots. 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 19 april 2017.

Device

Healon Ophthalmic Viscoelastic Devices
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Abbott Medical Optics Healon Ophthalmic Viscoelastic Devices
  • Manufacturer
    Abbott Medical Optics

Manufacturer

Abbott Medical Optics