Events

Recall of Healon Ophthalmic Viscosurgical Devices (OVD) 0.55mL

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by AMO Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2017-RN-00525-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-04-26
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00525-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Amo has identified the remote possibility that certain healon 0.55ml solutions in the affected lot 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. to date, no patient injuries have been reported to amo in connection with any of the affected healon 0.55ml.
  • Action
    AMO Australia is advising users to immediately stop using and remove the affected Healon 0.55ml lot from their inventory. Distributors are to stop shipping this lot. Product is to be returned to AMO for replacement.

Device

Healon Ophthalmic Viscosurgical Devices (OVD) 0.55mL
  • Model / Serial
    Healon Ophthalmic Viscosurgical Devices (OVD) 0.55mLLot Number: UB32514ARTG Number: 144891
  • Manufacturer
    AMO Australia Pty Ltd

Manufacturer

AMO Australia Pty Ltd