Events

Recall of Rayner Intraocular Lenses - Sulcoflex Aspheric 653L, Sulcoflex Torie 653T, C-flex Aspheric 970C, Superflex Aspheric 920H, Sulcoflex Aspherie 653L, T-flex Aspheric 623T

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-2016-RN-00044-2
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-01-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00044-2
  • 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
    Internal quality checks by the manufacturer rayner have revealed that certain products released to market may contain a higher than usual level of residual polishing compound (aluminium oxide) that is used in the manufacturing process of intraocular lenses (iols). there is a possibility that certain products released to market may contain levels that slightly exceed the internal limits for residual aluminium oxide levels. clinically significant levels of aluminium oxide have, on rare occasions been linked to cases of toxic anterior segment syndrome (tass) in published literature.
  • Action
    Customers are advised to inspect their stock and quarantine all affected stock so that Designs For Vision Pty Ltd (distributor) can arrange for quarantined stock to be recovered and replacement stock, or a credit note, issued. Surgeons are advised that if a lens subject to this recall has been implanted, it is recommended that as a precaution, healthcare professionals monitor patients for up to one month post-operatively for symptoms of TASS, in case of late onset presentation. This action has been closed-out on 09/05/2017.

Device

Rayner Intraocular Lenses - Sulcoflex Aspheric 653L, Sulcoflex Torie 653T, C-flex Aspheric 970C, ...
  • Model / Serial
    Rayner Intraocular Lenses - Sulcoflex Aspheric 653L, Sulcoflex Torie 653T, C-flex Aspheric 970C, Superflex Aspheric 920H, Sulcoflex Aspherie 653L, T-flex Aspheric 623TMultiple Models and Lot Numbers affectedARTG Number: 100926
  • Manufacturer
    Kevin Grundy (IBD) Pty Ltd

Manufacturer

Kevin Grundy (IBD) Pty Ltd