BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUTROGENA VISIBLY CLEAR LIGHT THERAPY ACNE MASK

    MDR report key: 12771637 · Received November 8, 2021

    Report

    Report Number
    2214133-2021-00046
    Event Type
    Injury
    Date Received
    November 8, 2021
    Date of Event
    December 5, 2020
    Report Date
    November 12, 2021
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    OLP
    UDI-DI
    3574661359182
    PMA / PMN Number
    K123999
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT IDENTIFIER, WEIGHT AND ETHNICITY WERE NOT PROVIDED FOR REPORTING. THIS REPORT IS FOR (NEUTROGENA VISIBLY CLEAR LIGHT THERAPY ACNE MASK EU (B)(4)). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA (NTG LIGHT THERAPY ACNE MASK USA 70501101247 7050110124USB 7050110124USB). UDI #: (B)(4), UPC: (B)(4), LOT #: 1757KS06, EXP DATE: NI. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. DEVICE HISTORY RECORDS REVIEW HAS BEEN REQUESTED. AT THIS TIME, THIS EVENT IS BEING REPORTED WITH AN OVERABUNDANCE OF CAUTION. ALTHOUGH VERY LIMITED INFORMATION WAS PROVIDED IN THIS CASE, CONSIDERING THAT THE CONSUMER¿S SYMPTOMS SEEM TO HAVE REMAINED AFTER DISCONTINUATION OF PRODUCT USE, THERE IS POTENTIAL FOR A PERMANENT CONDITION AND WAS ASSESSED AS SERIOUS. WHILE THE CONSUMER WAS SEEN BY DIFFERENT OPHTHALMOLOGISTS AND A CORNEA SPECIALIST, THERE IS INSUFFICIENT INFORMATION TO DETERMINE THE NATURE OF THE EYE CONDITION AND WHETHER IT IS POTENTIALLY CAUSALLY RELATED TO PRODUCT USE AS THERE IS NO INFORMATION ON MEDICAL HISTORY, CONCOMITANT MEDICATIONS, PROGRESSION OF THE CONDITION, RESULTS OF MEDICAL CONSULTATIONS OR DIAGNOSTICS DONE, FINAL DIAGNOSIS AND THE TREATMENTS GIVEN WERE NOT SPECIFIED ALONG WITH THE INDICATIONS. THE NEUTROGENA LIGHT THERAPY ACNE MASK AND ACTIVATOR WERE VOLUNTARILY WITHDRAWN FROM THE MARKET AT THE DISTRIBUTOR AND RETAIL LEVEL (REFERENCE MARKET WITHDRAWAL: NEUTROGENA LIGHT THERAPY ACNE MASK, REPORT NUMBER: (B)(4)). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    JOHNSON & JOHNSON CONSUMER, INC. IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH JOHNSON & JOHNSON CONSUMER, INC. HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, JOHNSON & JOHNSON CONSUMER, INC. OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, JOHNSON & JOHNSON CONSUMER, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. EXPIRATION DATE ¿ MAY 31, 2020, UDI - (B)(4). H4, H6: DEVICE HISTORY RECORDS REVIEW WAS COMPLETED. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION AND PRODUCT WAS MANUFACTURED PER SPECIFICATION. THE PRODUCT WAS MANUFACTURED ON JUNE 24, 2017. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE FOLLOW-UP 01 MEDWATCH, AN ADDITIONAL FOLLOW- UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    A MOTHER REPORTED AN ADVERSE EVENT OCCURRING WITH HER SON REGARDING THE NEUTROGENA VISIBLY CLEAR LIGHT THERAPY ACNE MASK. THIS CASE WAS RECEIVED FROM THE MOTHER OF A (B)(6) MALE WHO REPORTED THAT HER SON USED NTG VISIBLY CLEAR LIGHT THERAPY MASK FOR ACNE ONCE DAILY ON (B)(6) 2020 AND ON (B)(6) 2020, HE STARTED HAVING ¿EYE PROBLEMS¿ AND ¿¿COULD HARDLY SEE ON ONE EYE¿. THERE IS NO INFORMATION ON ACCOMPANYING SIGNS AND SYMPTOMS. AT UNSPECIFIED TIMES, THE CONSUMER WAS SEEN BY DIFFERENT OPHTHALMOLOGISTS AND WAS REFERRED TO A CORNEA SPECIALIST. ACCORDING TO THE MOTHER, THE CONSUMER HAD A ¿DAMAGED CORNEA¿ AND HE WAS GIVEN UNSPECIFIED DROPS AND PILLS. THERE ARE NO DETAILS INDICATION, DOSAGE AND DURATION OF THE TREATMENT. THERE IS ALSO NO INFORMATION RELEVANT MEDICAL HISTORY AND CONCOMITANT MEDICATIONS, ON THE TESTS CONDUCTED, RESULTS, DIAGNOSIS AND INDICATIONS OF THE TREATMENTS GIVEN. THE CONSUMER DISCONTINUED USE OF THE PRODUCT AT AN UNSPECIFIED TIME AND AT THE TIME OF REPORTING, THE SYMPTOMS WERE STILL PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1666710 NEUTROGENA VISIBLY CLEAR LIGHT THERAPY ACNE MASK OTC POWERED LIGHT BASED LASER FOR ACNE OLP JOHNSON & JOHNSON CONSUMER INC 3574661359182 1757KS06 3574661359182

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Male Required Intervention