inforMED
InjuryILY

IN LIGHT WELLNESS SYSTEM

Received Jan 30, 2017 · Event occurred Dec 30, 2016

Report MW5067595 · MDR key 6294201

Device

Generic name

Therapeutic Heating Lamp

Product problems

  • Device Operates Differently Than Expected

Patient

67 YR

  • Unspecified Infection
  • Keratitis
  • Unspecified Infection
  • Keratitis

Narrative

Description of Event or Problem

EXPOSURE TO "IN LIGHT WELLNESS SYSTEM" AGGRAVATED A PRE-EXISTING HERPESVIRAL KERATITIS (800.52) EYE INFECTION THAT WAS VIRTUALLY IN REMISSION. INFECTION WAS RE-IGNITED, WITH SIGNIFICANT INFLAMMATION AND DAMAGE TO MY CORNEA, DESPITE USE OF ZIRGEN AT THE TIME. THERE WERE NO WARNINGS OR QUESTIONS REGARDING EYE INFECTIONS, LIGHT WAS DIRECTED TO EYES. (B)(6) WAS THE PRACTITIONER WHO UTILIZED THE LIGHT THERAPY.