inforMED
InjuryOHS

BEAUTY SET SKINLED

Received Jul 20, 2026 · Event occurred Jul 2, 2026

Report MW5190850 · MDR key 25871968

Device

Generic name

Light Based Over The Counter Wrinkle Reduction

Manufacturer

Philips

Model number

BRE738

Patient

Not reported

  • Blurred Vision
  • Eye Burn

Narrative

Description of Event or Problem

ON THE FIFTH USE OF SKINLED SUFFERED TRANSIENT VISION LOSS/BLURRED VISION OF 10 MINUTES IN DURATION WITH FLASH BURNS TO EYES. IT DOESN'T COME WITH EYE GOGGLES. I HAVE TO PLACE WET TOWEL OVER MY EYES AND SUBSEQUENTLY OPHTHALMOLOGIST CONFIRMED LIGHT BURNS THE EYES. PLACED ON ANTIBIOTICS. ALSO AFTER RETURN, I REALIZED THAT THIS IS NOT A MEDICAL DEVICE WHILE ALL OTHER SIMILAR DEVICES ARE FDA APPROVED. WHY FDA DOESN'T APPROVE THIS DEVICE WHILE OTHERS ARE?