Events

Safety Alert for Catalys Precision 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
    2015-03-16
  • Event Date Posted
    2015-03-17
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150316a.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 catalys precision laser system medical device manufacturer, abbott medical optics, has issued a medical device safety alert concerning catalys precision laser system [software version: 3.00.05]. the manufacturer identified two issues: loss of suction during treatment which may result in scoring the cornea during lens fragmentation. for the cataract incision surgeon templates with software version 3.00.05, selecting and deselecting an eye then selecting the other eye will result in templates for both eyes having the same parameters. the manufacturer has provided instructions on how to detect and respond to loss of suction, and advised users to verify the parameters, architecture and location of the cataract incisions in the cataract incision surgeon templates before saving and before treatment. the manufacturer will provide a software update to resolve the second issue. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 17 march 2015.

Device

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

Manufacturer

Abbott Medical Optics