Events

Safety Alert for STAR Excimer Laser System

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

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
    2013-09-25
  • Event Date Posted
    2013-09-25
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130925.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
    Medical device safety alert: abbott medical optics star excimer laser system medical device manufacturer, abbott medical optics (amo) ltd, has issued a field safety notice concerning amo star excimer laser system. the affected models are s2, s3, s4 and s4 ir. amo is providing an advisory notice to all customers who use the affected products to make aware of an issue that has 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 a specific component found in a limited amount of star systems. if the system is found to have the component, amo will replace a printed circuit board in the laser at the next service visit. in the unlikely event that the star system loses both oblique and ring illumination, users are advised to contact the manufacturer for assistance. in addition, amo recommends users to use the lowest level of illumination required during the patient treatment in order to reduce high use conditions caused by the oblique and ring illumination lamps being on simultaneously. it is recommended that only two oblique lamps be used (not activating the optional third oblique lamp) in order to further reduce the remote possibility of complete illumination loss. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 25 september 2013.

Device

STAR Excimer Laser System
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Abbott Medical Optics STAR Excimer Laser System
  • Manufacturer
    Abbott Medical Optics

Manufacturer

Abbott Medical Optics