Events

Recall of TECNIS 1-Piece Intraocular Lens (IOL) with TECNIS iTEC Preloaded Delivery System PCB00

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-2016-RN-01151-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-09-02
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01151-1
  • 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 has become aware of a small number of tecnis 1-piece iols (two in australia) that may have been mislabelled with the wrong diopter power. this is due to an inspection equipment malfunction during manufacturing. there is potential for lenses to have out of specification diopter or resolution. use of a mislabelled iol could lead to potential unexpected post-operative refractive error.
  • Action
    Abbott are advising surgeons that if there were no issues identified during routine post-operative follow up, no further action is required regarding the implanted IOL. This action has been closed-out on 12/05/2017.

Device

TECNIS 1-Piece Intraocular Lens (IOL) with TECNIS iTEC Preloaded Delivery System PCB00
  • Model / Serial
    TECNIS 1-Piece Intraocular Lens (IOL) with TECNIS iTEC Preloaded Delivery System PCB00 Serial Numbers: 7138311403 and 7139121403ARTG Number: 203780
  • Manufacturer
    AMO Australia Pty Ltd

Manufacturer

AMO Australia Pty Ltd