BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLUE LIGHT DERMATOLOGY TREATMENT

    MDR report key: 4935570 · Received July 17, 2015

    Report

    Report Number
    MW5044592
    Event Type
    Injury
    Date Received
    July 17, 2015
    Date of Event
    September 5, 2013
    Report Date
    July 17, 2015
    Product Code
    MVF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013 I HAD THE BLUE LIGHT TREATMENT PERFORMED ON MY FACE/HEAD TO REMOVE THE PRE-CANCEROUS LESIONS FROM MY FACE AND, AS ADVISED, REMAINED INDOORS FOR TWO DAYS AFTERWARD. ON SATURDAY,(B)(4) I WOKE UP WITH A SLIGHT AMOUNT OF VISION LOSS IN MY LEFT EYE. BY (B)(4), WHEN I VISITED MY EYE DOCTOR, THE CONDITION HAD SLIGHTLY WORSENED. AFTER EXAMINATION, THE INITIAL DIAGNOSIS WAS THAT I HAD PROBABLY SUFFERED A SLIGHT STROKE DURING MY SLEEPING HOURS ON THE PREVIOUS FRIDAY NIGHT THAT CAUSED DAMAGE TO MY OPTIC NERVE RESULTING IN SOME VISION LOSS. THE FOLLOWING DAYS DURING THAT WEEK THE CONDITION WORSENED FURTHER AND WHEN I RETURNED TO MY EYE DOCTOR ON MONDAY, (B)(4) THE VISION HAD DETERIORATED TO THE POINT OF COMPLETE BLINDNESS. AFTER ANOTHER EXAMINATION HE REFERRED ME TO ANOTHER EYE DOCTOR AND I VISITED HIM THE FOLLOWING DAY. THIS EXAMINATION INCLUDED REMOVING SOME FLUID FROM THE EYE AND TESTING IT AGAINST THE VARIOUS STRAINS OF THE HERPES VIRUS. THE RESULT OF THE TEST INDICATED THAT THE SHINGLES VIRUS STRAIN WAS PRESENT IN THE FLUID AND THAT THIS HAD CAUSED THE BLINDNESS. THE FINAL THEORY WAS THAT, SINCE I HAD THE BLUE LIGHT TREATMENT JUST PRIOR TO THIS INCIDENT, THE SHOCK OF THE PROCEDURE PROBABLY AGITATED THE DORMANT SHINGLES VIRUS TO ATTACK MY OPTIC NERVE AND CAUSE THE RESULTING BLINDNESS. FINALLY, I MUST RELATE THAT DURING ALL OF THE ABOVE STATED INFORMATION I NEVER EXPERIENCED ANY PAIN IN MY EYE. IN THE INTERIM MY THOUGHTS HAVE WAVERED TO MANY AVENUES OF THEORIES AND, SINCE I HADN'T EXPERIENCED ANY OF THE PAIN THAT I'VE ALWAYS HEARD IS GENERALLY ASSOCIATED WITH A SHINGLES OUTBREAK, I KEEP WONDERING IF THE DOCTORS' CONCLUDING THEORY IS CORRECT. EVEN THOUGH THE SHINGLES VIRUS WAS DISCOVERED IN THE EYE FLUID IT MAY HAVE BEEN THERE, IN IT'S DORMANT STATE, FOR YEARS AND NOT SUDDENLY AGITATED TO HIT THE OPTIC NERVE. I KEEP RETURNING TO A POSSIBILITY THAT THE BLUE LIGHT TREATMENT ITSELF MAY HAVE BEEN THE CULPRIT. MY INVESTIGATION AS TO THE SIDE EFFECTS RESULTING FROM THIS PROCEDURE HAS NOT INDICATED ANYTHING OTHER THAN THE EXPECTED SKIN IRRITATION AND SUCH. TO THAT END, I AM NOW IN CONTACT WITH YOUR ASSOCIATION TO ASCERTAIN WHETHER OR NOT THE BLUE LIGHT TREATMENT, IN ITSELF, HAS CAUSED ANY SIMILAR CONDITION ON ANYONE ELSE THAT I AM EXPERIENCING. THANK YOU FOR YOUR HEARING MY THOUGHTS AND I WILL ANTICIPATE YOUR REPLY AS SOON AS POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465691 BLUE LIGHT DERMATOLOGY TREATMENT NONE MVF

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Other| S CRESTOR,| VALACYCLOVIR,| LEVOTHYROXINE,| PREDNISOLONE,| AZOPT,| COMBIGAN,| LUMIGAN,| LISINOPRIL,| OTC MEDS: VITAMIN D,| CALTRATE,| B-COMPLEX,| ASPIRIN.| RX MEDS: HYDREA,| AENOLOL,| POTASSIUM,