VISERA PRO XENON LIGHT SOURCE

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.

Description of Event or Problem

IT WAS REPORTED THE XENON LIGHT SOURCE EXHIBITED POWER SUPPLY MALFUNCTION. THE ISSUE OCCURRED DURING THE INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.