FDA Adverse Event Injury Summary report: N

NIRA PRECISION LASER

MDR report key: 21221397 · Received January 22, 2025

Report

Report Number
MW5165168
Event Type
Injury
Date Received
January 22, 2025
Date of Event
October 16, 2024
Report Date
January 17, 2025
Manufacturer
NIRA INNOVATIONS INC.
Product Code
OHS
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

I PURCHASED AND RECEIVED A NIRA PRECISION LASER MID-(B)(6) 2024. I USED IT ONCE A DAY, A COUPLE OF DAYS TWICE PER THEIR INSTRUCTIONS UNDER MY EYES AND AT MY BROW. I BEGAN TO EXPERIENCE REDNESS AND EXTREMELY DRY SKIN UNDER AND AROUND MY EYES. I STOPPED USING IT (B)(6) 2024. THE REDNESS AND DRY SKIN TURNED INTO A THICK DRY SKIN CRUST UNDER MY EYES AS THEY BEGAN TO SWELL, ITCH, AND SKIN BEGAN TO PEEL. USED .05 HYDROCORTISONE CREAM FOR A FEW DAYS WITH LITTLE TO NO IMPROVEMENT. I DID NOT WANT TO CONTINUE, AS HYDROCORTISONE IS KNOWN TO THIN YOUR SKIN, SO I STOPPED USING IT. I TRIED HOT COMPRESSES, COLD COMPRESSES, NON- ALLERGIC AND HE ONLY THING THAT WOULD KEEP THE CRACKING SKIN MOIST WAS AQUAFOR OINTMENT. I COULD NOT GO OUT WITH WITHOUT SUNGLASSES, AS IT WAS UNSIGHTLY. MY EYE SKIN CONTINUED TO SWELL, PEEL, ITCH, AND STAY RED. I SAW A DERMATOLOGIST IN (B)(6) 2024, AS I HAD TRIED EVERYTHING I COULD THINK OF. SHE SAID THE ONLY THING THAT MIGHT HELP WOULD BE OPZELURA, A BLACK BOX WARNING DRUG WITH POTENTIALLY SERIOUS SIDE EFFECTS, THAT WAS RECOMMENDED FOR USE NO LONGER THAN TWO WEEKS. THE DRY EYES HAS IMPROVED, BUT I AM LEFT WITH PERMANENT DISCOLORATION, LIKE A DARKER RING AROUND MY ENTIRE TEAR TROUGH. ALONG WITH LARGE EYE BAGS AND DEEPER WRINKLES THAN I HAD BEFORE I USED THE LASER. THERE MUST BE MORE PEOPLE THAN ME THAT HAVE HAD THIS EXPERIENCE WITH THIS PRODUCT. I AM SICK ABOUT IT, AS MY EYES NOW LOOK YEARS OLDER THAN THEY DID A LITTLE OVER SIX MONTHS AGO.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
607039 NIRA PRECISION LASER LIGHT BASED OVER THE COUNTER WRINKLE REDUCTION OHS NIRA INNOVATIONS INC.

Patients

Seq Age Sex Outcome Treatment
1 68 YR Female Other ARMOUR THYROID| BUPROPION| ESTRADIOL PATCH| NUTRALOL | PROGESTERONE| SPIRNOLACTONE| VIT C| VIT D