Events

Recall of KAMRA Corneal Inlay (inserted into the natural cornea to treat presbyopia ie, age related hyperopia (far sightedness))

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Ellex 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-2013-RN-01254-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-12-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01254-1
  • 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 manufacturer, acufocus is aware of reports of some cases involving use of ophthalmic laser applications in eyes containing kamra inlays. during laser treatment, the inlay may absorb the laser and produce heat. this may result in the inlay reducing in size and/or significant thermal damage. in some cases, there were secondary damage to the cornea resulting in scarring. as a result of these case reports, ellex is providing additional warnings and information relative to the application of various ophthalmic procedures with a kamra inlay in situ.
  • Action
    The manufacturer has advised the inlays are not defective and function as intended. The purpose of this notification is to provide additional warnings and information with regard to further treatment to patients implanted with the KARMA inlay.

Device

KAMRA Corneal Inlay (inserted into the natural cornea to treat presbyopia ie, age related hyperop...
  • Model / Serial
    KAMRA Corneal Inlay (inserted into the natural cornea to treat presbyopia ie, age related hyperopia (far sightedness))ARTG Number: 182104
  • Manufacturer
    Ellex Australia Pty Ltd

Manufacturer

Ellex Australia Pty Ltd