Events

Recall of Z Hyalin Multipacks and Z Hyalin Plus Multipacks (aqueous/vitreous (eye) humour replacement medium kit)Z Hyalin Multipacks

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-2012-RN-01218-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-12-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01218-1
  • 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 manufacturer has identified a potential issue relating to the sterile integrity of the pouches. the seal of the pouch for each individual syringe might not be adequate and sterility of the outer surface could be compromised. the sterility of the syringe contents is not affected.
  • Action
    Quarantine and dispose of the affected product appropriately.

Device

Z Hyalin Multipacks and Z Hyalin Plus Multipacks (aqueous/vitreous (eye) humour replacement mediu...
  • Model / Serial
    Z Hyalin Multipacks and Z Hyalin Plus Multipacks (aqueous/vitreous (eye) humour replacement medium kit)Z Hyalin MultipacksLot numbers: 1218AB, 1218AC, 1119AE, 1207AE, 1192BAZ Hyalin Plus MultipacksLot numbers: 2190BA, 2192AA, 2192ABARTG Number: 150016
  • Manufacturer
    Carl Zeiss Pty Ltd

Manufacturer

Carl Zeiss Pty Ltd