Events

Recall of Alcon Labs Accurus Consumables (IIb) - 45150

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
    20167
  • Event Initiated Date
    2016-05-18
  • 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
    Due to the possible presence of a moulding irregularity found within the aspiration lue may result in a reduction of vacuum within the aspiration line. the affected lots may result in a small air leak and corresponding reduction in vacuum performance, leading to inability to achieve or reach maximum targeted vacuum and reduction of holding force at distal end of the phaco tip.
  • Action
    Product to be exchanged

Device

Alcon Labs Accurus Consumables (IIb) - 45150
  • Model / Serial
    Model: 8065752192, 8065752200, Affected: 1794552H, 1799602H, 1799605H
  • Manufacturer
    Alcon Laboratories Inc

Manufacturer

Alcon Laboratories Inc