Events

Recall of Rayner T-Flex Aspheric 623T Intraocular Lens (Posterior chamber intraocular lenses)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Kevin Grundy (IBD) 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-01146-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2012-11-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01146-1
  • 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 paper pouches used for packaging the intraocular lens have a deficiency which may result in sterility failure. the affected batches are under the control of the distributor are being recalled.
  • Action
    The distributor has been asked to return all affected products to the sponsor, Kevin Grundy (IBD) Pty Ltd

Device

Rayner T-Flex Aspheric 623T Intraocular Lens (Posterior chamber intraocular lenses)
  • Model / Serial
    Rayner T-Flex Aspheric 623T Intraocular Lens (Posterior chamber intraocular lenses)Batch Numbers: 102E4206401, 102E4206402 & 102E4207001ARTG Number: 100926
  • Manufacturer
    Kevin Grundy (IBD) Pty Ltd

Manufacturer

Kevin Grundy (IBD) Pty Ltd