BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIRA PRECISION LASER

    MDR report key: 22062649 · Received May 21, 2025

    Report

    Report Number
    MW5170671
    Event Type
    Injury
    Date Received
    May 21, 2025
    Date of Event
    April 1, 2025
    Report Date
    May 16, 2025
    Manufacturer
    NIRA SKINCARE / NIRA INNOVATIONS INC.
    Product Code
    OHS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I PURCHASED A NIRA PRECISION LASER IN (B)(6) 2025, WHICH IS FDA APPROVED. AFTER USING THE PRODUCT FOR A COUPLE OF MONTHS, I NOTICED THAT ONE OF MY EYES DEVELOPED AN INTERMITTENT SPASM OR TWITCH. I BELIEVE IT IS DUE TO THE PRODUCT, AS I'VE USED NO OTHER DIFFERENT PRODUCT, DEVICE, OR DONE ANYTHING DIFFERENTLY SINCE THAT TIME. I'VE DISCONTINUED USE AND WOULD NEVER RECOMMEND THIS PRODUCT TO ANYONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2322014 NIRA PRECISION LASER LIGHT BASED OVER THE COUNTER WRINKLE REDUCTION OHS NIRA SKINCARE / NIRA INNOVATIONS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female CALCIUM/MAGNESIUM. | COQ10.| FISH OIL. | MULTI-VITAMIN.