Important Safety Alerts

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