Events

Recall of Algerbrush II and Algerbrush II Accessories Algerbrush – II Rust Ring 0.5mm instrument and Rust Ring 1.0mm instrument Algerbrush – II Accessories0.5mm Burr/Chuck and 1.0mm Burr/Chuck

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by iNova Pharmaceuticals 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-2016-RN-01586-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-12-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01586-1
  • 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
    The operating instructions for sterilisation (version 2) were either missing or obsolete. the new operating instructions (version 3) contain specific time and temperature for sterilisation. failure to follow the new operating instructions may result in potential adverse events, including eye infections.
  • Action
    iNova Pharmaceuticals is advising health practitioners to replace their Algerbrush-II Operating Instructions (v2) with the new instructions provided (v3) and to ensure that all relevant staff is informed of this change to the operating instructions. This action has been closed-out on 27/06/2017.

Device

Algerbrush II and Algerbrush II Accessories Algerbrush – II Rust Ring 0.5mm instrument and Rust R...
  • Model / Serial
    Algerbrush II and Algerbrush II AccessoriesAlgerbrush – II Rust Ring 0.5mm instrument and Rust Ring 1.0mm instrument Algerbrush – II Accessories0.5mm Burr/Chuck and 1.0mm Burr/Chuck ARTG Number: 93755
  • Product Classification
    Ophthalmic Devices
  • Manufacturer
    iNova Pharmaceuticals Australia Pty Ltd

Manufacturer

iNova Pharmaceuticals Australia Pty Ltd