Events

Recall of Alcon 23 Gauge and 25 Gauge Valved entry systems (cannulas designed to allow entry of instruments to the back of the eye during ophthalmic surgery)

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-2015-RN-00751-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-08-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00751-1
  • 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
    It has been identified that a small percentage of the single-use 23 gauge and 25 gauge valved entry systems have the potential to leak beyond their design specification. leakage of fluid during ophthalmic surgery can lead to fluctuations of intraocular pressure (iop) in patients. the occurrence of a leaking valved cannula is easily detectable to the user intra-operatively as there will be visible leaking of fluid/saline solution from the entry point of the cannula prior to performing surgery.
  • Action
    To prevent fluctuations of IOP during surgery, surgeons can use the Constellation Vision System’s IOP control feature. Alternatively a plug can be inserted the valve entry system. Alcon is providing standalone plugs to be inserted into affected valve entry systems in the event that unwanted leakage is detected. This action has been closed-out on 17/08/2016.

Device

Alcon 23 Gauge and 25 Gauge Valved entry systems (cannulas designed to allow entry of instruments...
  • Model / Serial
    Alcon 23 Gauge and 25 Gauge Valved entry systems (cannulas designed to allow entry of instruments to the back of the eye during ophthalmic surgery)Valved Entry Systems sold as standalone and contained within CONSTELLATION TOTALPLUS Paks and Alcon CUSTOM-PAKS Product Numbers:8065 751 585, 8065 751 586, 8065 751 657, 8065 751 658, 8065 751 900, 8065 751 902, 8065 751 908, 8065 751 910ARTG Number: 148011 and 145666
  • Manufacturer
    Alcon Laboratories Australia Pty Ltd

Manufacturer

Alcon Laboratories Australia Pty Ltd