Events

Safety Alert for STAR S4 IR Excimer Laser System Software, Versions 5.00 through 5.22 and Versions 5.00 through 5.30

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Abbott Medical Optics (AMO).

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2011-07-20
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20110720.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Advisory notice: abbott medical optics (amo) star s4 ir excimer laser system software, versions 5.00 through 5.22 and versions 5.00 through 5.30 abbott medical optics (amo) has issued an advisory notice to customers of amo star s4 ir excimer laser system and customers of amo wavescan wavefront system regarding a defect of the iris registration (ir) software on the star s4 ir excimer laser system, versions 5.00 through 5.22 and versions 5.00 through 5.30 respectively. there is a malfunction of the compensation for pupil centroid shift in the affected software versions, which may lead to visual disturbances or reduced best corrected visual acuity. according to the local supplier, the affected products are available in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

STAR S4 IR Excimer Laser System Software, Versions 5.00 through 5.22 and Versions 5.00 through 5.30
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: [20 Jul 2011] Abbott Medical Optics (AMO) STAR S4 IR Excimer Laser System Software, Versions 5.00 through 5.22 and Versions 5.00 through 5.30
  • Manufacturer
    Abbott Medical Optics (AMO)

Manufacturer

Abbott Medical Optics (AMO)