BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEROXICLEAR HYDROGEN PEROXIDE SOLUTION

    MDR report key: 6054827 · Received October 25, 2016

    Report

    Report Number
    0001313525-2016-00485
    Event Type
    Injury
    Date Received
    October 25, 2016
    Date of Event
    April 24, 2015
    Report Date
    July 20, 2015
    Manufacturer
    BAUSCH & LOMB INCORPORATED
    Product Code
    LPN
    PMA / PMN Number
    K132216
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLAINT SAMPLE WAS RETURNED FOR EVALUATION AND THE RESULTS OF THE CHEMICAL TESTING PERFORMED WERE CONSISTENT WITH SHELF LIFE LIMITS. ON (B)(6) 2015, CONSUMER REPORTED HER EYES TURN RED BY THE END OF THE DAY WHEN USING THE PRODUCT AND THAT SHE HAD SOUGHT MEDICAL ATTENTION. MEDICAL INFORMATION PROVIDED BY DOCTOR OFFICE INDICATED OFFICE VISITS ON (B)(6) 2015. AT (B)(6) VISIT, RECORDS INDICATED PATIENT USED CLEAR CARE. DOCTOR RECORDED GPC WITH BOTH EYES, DIAGNOSED CHRONIC ALLERGIC CONJUNCTIVITIS AND RECOMMENDED ZADITOR. IN ADDITION, THE DOCTOR DIAGNOSED EYELID ECZEMATOUS DERMATITIS AND RECOMMENDED LID SCRUBS AND MAXITROL FOR THE RIGHT EYE. THE (B)(6) VISIT WAS FOR REFITTING WITH A DIFFERENT CONTACT LENS, AND THE (B)(6) WAS A FOLLOW-UP VISIT. AT BOTH VISITS, THE DOCTOR RECORDED GPC IN BOTH EYES. IN ADDITION, THE (B)(6) VISIT INDICATED CLEAR CARE WAS RECOMMENDED. WHILE THE CONSUMER INDICATED HER EYES TURN RED BY THE END OF THE DAY WHEN USING PEROXICLEAR AND SHE RETURNED A BOTTLE OF PEROXICLEAR, THE DOCTOR RECORDS INDICATE THAT THE PATIENT WAS USING CLEAR CARE WHEN MEDICAL TREATMENT WAS ADMINISTERED FOR CHRONIC ALLERGIC CONJUNCTIVITIS AND EYELID ECZEMATOUS DERMATITIS. THE MEDICAL RECORDS DO NOT SUPPORT INJURY ASSOCIATED WITH THE PEROXICLEAR PRODUCT. NOTE THAT THIS EVENT IS BEING RETROSPECTIVELY REPORTED TO FDA DUE TO THE RESULT OF A REMEDIATION ACTIVITY.

    Description of Event or Problem · 1

    PATIENT REPORTED HER EYES TURN RED BY THE END OF THE DAY AND THAT MEDICAL ATTENTION WAS SOUGHT. MEDICAL INFORMATION PROVIDED BY DOCTOR OFFICE INDICATED PATIENT HAD 3 OFFICE VISITS. THE RECORD INDICATED FOR THE FIRST VISIT THE PATIENT USED CLEAR CARE. THE PATIENT REPORTED EYE ITCH, "RED SPOTS" ON RIGHT UPPER AND LOWER EYELIDS AND THAT SHE HAD BEEN RUBBING HER EYES BECAUSE THEY ITCH. DOCTOR RECORDED GIANT PAPILLARY CONJUNCTIVITIS(GPC) WITH BOTH EYES, DIAGNOSED CHRONIC ALLERGIC CONJUNCTIVITIS AND RECOMMENDED ZADITOR. IN ADDITION, THE DOCTOR DIAGNOSED EYELID ECZEMATOUS DERMATITIS AND RECOMMENDED LID SCRUBS AND MAXITROL FOR THE RIGHT EYE. THE DOCTOR ALSO NOTED PANNUS IN THE LEFT EYE. TWO WEEKS LATER, PATIENT VISITED TO TRY NEW CONTACT LENSES. THE DOCTOR REPORTED THE PATIENT STILL HAD GPC IN BOTH EYES, THE PANNUS IN THE LEFT EYE, AND THAT THE EYELID ECZEMATOUS DERMATITIS RESOLVED WITH TREATMENT. THE PATIENT WAS REFIT WITH DIFFERENT CONTACT LENSES. PATIENT RETURNED A WEEK LATER FOR FOLLOW-UP. THE PATIENT STILL HAD GPC IN BOTH EYES AND THE PANNUS ASSOCIATED WITH LEFT EYE. THE PATIENT RETURNED TO THE ORIGINAL CONTACT LENSES AND THE RECORDS INDICATED THAT CLEAR CARE WAS RECOMMENDED. NO ADDITIONAL INFORMATION WAS PROVIDED BY THE PRACTITIONER. THE COMPLAINT SUGGESTS THE DEVICE MAY HAVE MALFUNCTIONED AS A RESULT OF VARIABILITY OF THE NEUTRALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705782 PEROXICLEAR HYDROGEN PEROXIDE SOLUTION ACCESSORIES, SOFT LENS PRODUCTS LPN BAUSCH & LOMB INCORPORATED GB15126

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other CLEAR CARE