Events

Recall of Carl Zeiss Master 500

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
    15544
  • Event Initiated Date
    2013-10-21
  • 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
    The ulib database delivered with new devices as well as the ulib database offered between march 25 and sept 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., specifically the a0 constant of the lens amo sensar as40e is listed as 0.0 in the internal lens data base of the iol master. the correct value is -2.420.
  • Action
    Manufacturer to issue advice regarding use

Device

Carl Zeiss Master 500
  • Model / Serial
    Model: 000000-1692-983; 1789-811, 1322-734, 1262-306, 1262-307, 9004-00, 1064-064 and 1134-078, Affected:
  • Manufacturer
    Carl Zeiss Meditec AG

Manufacturer

Carl Zeiss Meditec AG