Events

Recall of Amo STAR Excimer Laser System

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by AMO Manufacturing USA, LLC.

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
    15562
  • Event Initiated Date
    2013-10-30
  • 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: AMO Australia Pty Limited (NZ), c/- Exel New Zealand Limited, 3 - 5 Westfield Place, Mt Wellington, Auckland
  • Reason
    There is the potential to result in loss of illumination due to an unexpected failure of a component under high use conditions of the oblique and ring illumination lamps. this issue can be traced to overheating of a specific component found in a limited amount of star systems, which can result in a burning smell coming from the laser system. it does not affect laser pulse delivery. the treatment can continue without illumination of the surgical field at the surgeon's discretion. since all treatment steps (pulse by pulse) are stored in non-volatile memory, in the event of treatment interruption, when illumination is restored the surgeon can resume the treatment at the point where it was interrupted.
  • Action
    Product to be modified

Device

Amo STAR Excimer Laser System

Manufacturer

AMO Manufacturing USA, LLC