VISERA XENON LIGHT SOURCE

Description of Event or Problem

IT WAS REPORTED THE LIGHT SOURCE HAD INSUFFICIENT BRIGHTNESS. THIS WAS FOUND DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

Additional Manufacturer Narrative

THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.