Events

Recall of Carl Zeiss IOLMaster

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Carl Zeiss Meditec AG.

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
    19345
  • Event Initiated Date
    2015-11-09
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Carl Zeiss (NZ) Ltd, 22 Fremlin Place, Avondale, Auckland 1026
  • Reason
    Due to a software defect iol calculation printouts and exported reports can contain wrong iol power data (mix-up of lens types; calculated iol power does not fit to stated lens type) if a specific and unusual operator sequence is followed and the healthcare provider does not recognize that the second calculation is identical to the first although a different lens type was selected., this could lead to order and implantation of iols with wrong lens power and to (correctable) impairment of patient's visual acuity.
  • Action
    Software to be upgraded

Device

Carl Zeiss IOLMaster
  • Model / Serial
    Model: 000000-1692-983, Affected: , Software version: 7.5.2, 7.7.2 and 7.7.3
  • Manufacturer
    Carl Zeiss Meditec AG

Manufacturer

Carl Zeiss Meditec AG