inforMED
InjuryORZ

TEARCARE

Received Jan 2, 2025 · Event occurred Jan 6, 2022

Report MW5164267 · MDR key 21071695

Device

Generic name

Eyelid Thermal Pulsation System

Patient

54 YR · Female

  • Skin Discoloration
  • Skin Discoloration

Narrative

Description of Event or Problem

I HAD A TEARCARE PROCEDURE FOR MY DRY EYES IN DR. (B)(6) OFFICE (B)(6) 2022 AND A MONTH LATER MY EYELIDS TURNED A DARK PURPLE AND HAVE BEEN THAT WAY SINCE PROCEDURE. I REACHED OUT TO COMPANY AND REPORTED AND ASKED THEM TO REPORT AND THEY SAID THEY HAVEN'T HAD ISSUES. I VISITED AN PLASTIC OPHTHALMOLOGIST. AT MASS EYE AND SHE BIOPSIED TO SEE IF ANY IRON OR OTHER CHEMICALS AND NOTHING WAS FOUND. MY DERMATOLOGIST WAS SO CONCERNED THAT I WAS A PATIENT AT (B)(6) AND WOMENS DERMATOLOGY ROUNDS THIS SUMMER (B)(6) 2024 AND THE DERMATOLOGISTS THOUGHT IT PROBABLY HAD TO DO WITH THE DRY EYE PROCEDURE, AND I HAVE HAD A COUPLE FRAXEL LASERS AT MGH AND THEY HAVE HELPED BUT I WOULD LIKE TO REPORT THIS AND ALSO LET ME KNOW IF OTHERS HAVE REPORTED.