InjuryILY

NEUROCARE PRO

Received Dec 15, 2025 · Event occurred Dec 4, 2025

Report MW5180518 · MDR key 23806665

Device

Generic name

Lamp, Infrared, Therapeutic Heating

Manufacturer

Neurocare Pro Llc

Model number

BRAIN CAP 280

Catalog number

THERE IS NO NUMBER AVAILABLE

Lot number

THERE IS NO LOT ON THE LABEL

Product problems

Material Integrity Problem
Patient Device Interaction Problem

Patient

87 YR · Female

Loss of Vision
Vitreous Hemorrhage
Superficial (First Degree) Burn
Swelling/ Edema
Loss of Vision
Vitreous Hemorrhage
Superficial (First Degree) Burn
Swelling/ Edema

Narrative

Description of Event or Problem

I RECEIVED THREE MEDICAL DEVICES FROM (B)(6) AT NEUROCARE PRO. ONE OF THE PRODUCTS IS BRAIN CAP 280. THE PRODUCT IS FDA REGISTERED DEVICE INFORMATION PRODUCT: NEUROCARE PRO BRAIN CAP / RED LIGHT THERAPY PAD MANUFACTURER: NEUROCARE PRO LLC ESTABLISHMENT REGISTRATION # 3018126456 EVENT DATE: (B)(6) 2025 EVENT LOCATION: PRIVATE RESIDENCE THE EVENT OR PROBLEM AN 87-YEAR-OLD FEMALE USED THE NEUROCARE PRO BRAIN CAP FOR SIX MINUTES. THE DEVICE IS MARKETED AS "NON-THERMAL." WITHIN MINUTES SHE DEVELOPED SEVERE PERIORBITAL SWELLING AND A LARGE SUBCONJUNCTIVAL / INTRAOCULAR HEMORRHAGE WITH PERSISTENT BLOOD AND VISION LOSS IN THE AFFECTED EYE. INCLUDING A BURN. MEDICAL EVALUATION IS ONGOING. INDEPENDENT TESTING SHOWS THE DEVICE HAS NO PULSING CIRCUITRY AND USES ONLY SINGLE-DIE COMMODITY LEDS, CONFIRMING THE "NON-THERMAL" AND "ADVANCED PULSING" CLAIMS ARE FALSE. IN FACT, THERE ARE NO SPECIALIZED CHIPS OR CIRCUITRY. I OBTAINED A VERY DETAILED ENGINEERING REPORT ON THIS DEVICE AND NOTHING THEY CLAIM ON THE WEBSITE IS CORRECT. INCLUDING WHERE THE DEVICE IS MANUFACTURED. I HAVE VIDEO, REPORTS IF NEEDED.