Events

Recall of IOLMaster (used for the treatment of axial length, corneal curvature, anterior chamber depth and for the determination of the white-to-white distance (WTW) of the human eye, as well as for the calculation of the required intraocular lens)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Carl Zeiss 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-01070-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-10-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01070-1
  • 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 ulib database delivered with new devices as well as the ulib database offered between march 25 and september 24, 2013 for download contained an erroneous value for one lens. this could lead to the implantation of a lens with a wrong diopter value. specially the a0 constant of the lens amo sensar ar40e is listed as 0.0 in the internal lens database of the iolmaster. the correct value is -2.420. the a0 value is only relevant if the haigis-formula or haigis-l-formula are used. therefore, users that use the amo sensar ar40e and one of the two haigis formulas are affected.
  • Action
    Carl Zeiss is providing users with instructions on how to correct the a0 constant of the AMO Sensar AR40E on the affected IOLMaster systems and instructions on how to download the corrected database.

Device

IOLMaster (used for the treatment of axial length, corneal curvature, anterior chamber depth and ...
  • Model / Serial
    IOLMaster (used for the treatment of axial length, corneal curvature, anterior chamber depth and for the determination of the white-to-white distance (WTW) of the human eye, as well as for the calculation of the required intraocular lens)ARTG Number: 128166
  • Manufacturer
    Carl Zeiss Pty Ltd

Manufacturer

Carl Zeiss Pty Ltd