Events

Recall of Alcon Valved Entry System 3CT, 23Ga and 25Ga

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Alcon Laboratories Inc.

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
    19003
  • Event Initiated Date
    2015-08-27
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Alcon Laboratories Australia Pty Ltd (NZ), c/- Pharmaco (NZ) Ltd, 4 Fisher Crescent, Mt Wellington, Auckland
  • Reason
    The manufacturer advises that specific lots of its 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.
  • Action
    Manufacturer to issue advice regarding use

Device

Alcon Valved Entry System 3CT, 23Ga and 25Ga
  • Model / Serial
    Model: 8065 751 657 (23Ga), 8065 751 658 (25Ga), Affected: Selected lots
  • Manufacturer
    Alcon Laboratories Inc

Manufacturer

Alcon Laboratories Inc