Events

Safety Alert for Healon EndoCoat Ophthalmic Viscosurgical Device

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
    2014-11-19
  • Event Date Posted
    2014-11-19
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20141119.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 endocoat ophthalmic viscosurgical device medical device manufacturer, abbott medical optics (amo) inc., has issued an advisory notice concerning the healon endocoat ophthalmic viscosurgical device (ovd) with the product number vt585. the advisory notice intends to re-emphasize proper techniques for the use of the syringe included in the healon endocoat directions for use (dfu). it provides an additional diagram regarding recommended syringe orientation to avoid finger grip dislodgement. the manufacturer has received complaints where the finger grip dislodged while depressing the syringe plunger. the finger grip dislodgement could result in the surgeon’s hand unintentionally moving the cannula further than intended, resulting in potential trauma to the eye. failure to follow the dfu can result in the finger grip becoming detached. specifically, the cannula should be fastened securely to the syringe: however, over tightening may cause the hub to weaken and possibly detach from the syringe. extrusion of a test drop is recommended prior to entering the eye, and excessive force on the plunger should be avoided. the manufacturer advises users to consult the dfu that is distributed with each device, which contains important warnings, and precautions for use of the product. according to the manufacturer, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 19 november 2014.

Device

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

Manufacturer

Abbott Medical Optics