Events

Recall of Torix Disposable Toric IOL Marking and Alignment System

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Designs for Vision Aust 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-2013-RN-00313-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2013-04-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00313-1
  • 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 outer carton of these products has a 12 month expiry date (2013-12), the inner product has a 6 month expiry date (2013-02).
  • Action
    Customers are asked to inspect their stock and quarantine all affected units so that Ingeneus can recover quarantined units.

Device

Torix Disposable Toric IOL Marking and Alignment System
  • Model / Serial
    Torix Disposable Toric IOL Marking and Alignment SystemProduct codes: HYX-FG-02510 (10 sets sterilised)HYX-M-02512 (single pack)HYX-M-02530 (Intra-operative Axis Guide)HYX-M-02515 (Pre-operative Marker & Handle)Lot number: W06710ARTG Number: 200725
  • Manufacturer
    Designs for Vision Aust Pty Ltd

Manufacturer

Designs for Vision Aust Pty Ltd