VISERA PRO XENON LIGHT SOURCE

Description of Event or Problem

IT WAS REPORTED THE XENON LIGHT SOURCE EXPERIENCED FRONT PANEL BLINKING DURING SET UP. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

E1: (B)(6). THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.