Events

Recall of AMO Tecnis CL Foldable Silicone IOL (Intraocular lens) with OptiEdge Design (Intraocular lenses indicated for primary implantation for the visual correction of aphakia in adults)

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-2014-RN-00120-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-02-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00120-1
  • 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
    Abbott medical optics is issuing this hazard alert because certain silicone tecnis iol s may have been labelled with the incorrect diopter power. a mislabelled iol could lead to potential unexpected postoperative refractive error and may result in a secondary surgical intervention to correct the issue.
  • Action
    AMO Australia is providing the implanting surgeon with advice on the treatment of the patient implanted with the affected unit.

Device

AMO Tecnis CL Foldable Silicone IOL (Intraocular lens) with OptiEdge Design (Intraocular lenses i...
  • Model / Serial
    AMO Tecnis CL Foldable Silicone IOL (Intraocular lens) with OptiEdge Design (Intraocular lenses indicated for primary implantation for the visual correction of aphakia in adults)Model Number: Z9002Serial Number: 1231181309ARTG Number: 170331
  • Manufacturer
    AMO Australia Pty Ltd

Manufacturer

AMO Australia Pty Ltd