Events

Recall of LaserEdge Knives

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-2017-RN-00366-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-03-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00366-1
  • 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
    Inova pharmaceuticals (australia) pty ltd (inova) is conducting an urgent recall of 82 lots of 11 laseredge knife skus used in ophthalmic surgery due to an atypical number of dull blade complaints. if excessive force is required to push a dull blade through the cornea this may result in a sub-optimal incision. uncontrolled penetration through the cornea may also result in injury to anterior segment structures.Patients undergoing posterior segment surgery (e.G. vitrectomy) are at potential risk for suprachoroidal haemorrhage or retinal injury which, in rare instances, may be associated with permanent loss of vision. the likelihood of adverse events associated with dull blades is very low.
  • Action
    Customers are notified to inspect their stock immediately and quarantine affected stock of LaserEdge knives. iNova (Bausch + Lomb) will arrange for the stock return and provide a credit for the stock returned.

Device

LaserEdge Knives

Manufacturer

iNova Pharmaceuticals Australia Pty Ltd