Events

Recall of IOLMaster 500, software version 7.5.2, 7.7.2 and 7.7.3(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-2015-RN-01065-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-11-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01065-1
  • 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
    These versions of software have a software defect which can result in incorrect iol calculations being presented on screen and in a printout/export in rare cases when a specific non-standard workflow is used. this could lead to order and implantation of iols with wrong lens power and to (correctable) impairment of patient's visual acuity.
  • Action
    To correct the software anomaly users are advised to perform the software update to version 7.5.3 or 7.7.4 using the USB stick by following the instructions provided in customer letter. This action has been closed-out on 31/08/2016.

Device

IOLMaster 500, software version 7.5.2, 7.7.2 and 7.7.3(used for the treatment of axial length, co...
  • Model / Serial
    IOLMaster 500, software version 7.5.2, 7.7.2 and 7.7.3(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