inforMED
OtherFTC

MULTILIGHT

Received Jun 18, 2002 · Event occurred May 17, 2002

Report MW1025356 · MDR key 401021

Device

Generic name

Intense Pulsed Light

Manufacturer

Lumenis

Model number

*

Catalog number

*

Lot number

*

Product problems

  • Use of Device Problem

Patient

44 YR

  • Pain
  • Burning Sensation

Narrative

Description of Event or Problem

PT HAD A FOTOFACIAL TREATMENT AT A LOCAL DERMATOLOGIST WHO USED THE MULTILIGHT, INTENSE PULSED LIGHT MACHINE. THEY HAVE BEEN EXPERIENCING VERY PAINFUL AND CONSTANT SIDE EFFECTS EVER SINCE. DURING THE TREATMENT, THE MULTILIGHT WAS INADVERTENTLY DIRECTED INTO PT'S UN-PROTECTED EYE. PT FELT IMMEDIATE BURNING AND PAIN IN THE EYE, AND NOW, OVER A MONTH LATER, THE PAIN STILL REMAINS. PT HAS BEEN TO AN OPHTHALMOLOGIST, A RETINAL SPECIALIST, AND NEUROLOGIST, AND ALL THREE, WHILE UNFAMILIAR WITH THE MULTILIGHT, COULD FIND NO PHYSICAL DAMAGE. PT IS SIMPLY LOOKING FOR ANSWERS AND WISH TO STOP THE PAIN. PT ASKS WHAT COULD BE HAPPENING TO CAUSE THE PERSISTENT PAIN. THEY REQUEST RESOURCES FOR INFO CONCERNING STUDIES AND TESTING ON THIS MACHINE AND ANY SUGGESTIONS FOR A COURSE OF ACTION TO RESOLVE THE ONGOING, 24 HR-A-DAY PAIN. PT ASKS IF THIS HAS BEEN APPROVED BY THE FDA AND IF THERE IS A REGULATORY BODY FOR THIS IN THEIR STATE.