Events

Recall of Alcon INFINITI Ultrasound PAKs - INFINITI Microsmooth Tapered Kelman 30°(Ophthalmic Surgical Procedure Kit used with INFINITI Vision System)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Alcon Laboratories Australia 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-2014-RN-01184-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-11-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01184-1
  • 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
    Alcon received complaints for the infiniti ultrasound paks related to occlusion of the aspiration line. the investigation identified equipment misalignment during manufacturing which may have potentially detached a piece of the aspiration tubing and inserted it into the aspiration line of the infiniti ultrasound paks. alcon is conducting this medical device recall due to the fact that the possibility exists for a loss of aspiration flow and / or occlusions of the aspiration line during surgery which may pose a safety risk to patients.
  • Action
    Alcon is requesting the users to immediately stop further use and segregate the affected lots of INFINITI Ultrasound PAKs. Replacement stock will be issued for units that are returned to Alcon. This action has been closed-out on 18/03/2016.

Device

Alcon INFINITI Ultrasound PAKs - INFINITI Microsmooth Tapered Kelman 30°(Ophthalmic Surgical Proc...
  • Model / Serial
    Alcon INFINITI Ultrasound PAKs - INFINITI Microsmooth Tapered Kelman 30°(Ophthalmic Surgical Procedure Kit used with INFINITI Vision System) Catalogue Number: 8065750280Lot Number: 1628714HARTG number: 141454
  • Manufacturer
    Alcon Laboratories Australia Pty Ltd

Manufacturer

Alcon Laboratories Australia Pty Ltd