BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEROXICLEAR HYDROGEN PEROXIDE SOLUTION

    MDR report key: 6139362 · Received December 1, 2016

    Report

    Report Number
    0001313525-2016-00713
    Event Type
    Malfunction
    Date Received
    December 1, 2016
    Report Date
    November 3, 2016
    Manufacturer
    BAUSCH & LOMB INCORPORATED
    Product Code
    LPN
    PMA / PMN Number
    K132216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CONSUMER REPORTED EXPERIENCING A BURNING AND STINGING SENSATION WHILE USING THE PRODUCT. THE (B)(6) DESCRIBES THE SCOPE OF INJURY ASSOCIATED WITH HYDROGEN PEROXIDE EXPOSURE TO THE OCULAR TISSUE, ¿HYDROGEN PEROXIDE IS IRRITATING TO THE EYES WITH A BURNING SENSATION, CONJUNCTIVAL HYPEREMIA, LACRIMATION AND SEVERE PAIN WHICH RESOLVES WITHIN A FEW HOURS. THERE ARE RARE CASES OF TEMPORARY CORNEAL INJURY RESULTING FROM THE APPLICATION OF 3% SOLUTION TO THE EYE ON CONTACT LENSES INCLUDING PUNCTUATE STAINING OF THE CORNEA, DECREASED VISION, CORNEAL OPACITY AND EDEMA.¿ THE SYMPTOMS REPORTED ARE CONSISTENT WITH THE (B)(6) DESCRIPTION OF A TEMPORARY CONDITION ASSOCIATED WITH HYDROGEN PEROXIDE EXPOSURE. NO PRODUCT WAS RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    CONSUMER REPORTED EXPERIENCING A BURNING AND STINGING SENSATION WHILE USING THE PRODUCT. THERE WAS NO REPORT OF A MEDICAL EVALUATION OR MEDICAL TREATMENT ASSOCIATED WITH THE EXPERIENCE. THE COMPLAINT SUGGESTS THE DEVICE MAY HAVE MALFUNCTIONED AS A RESULT OF VARIABILITY OF NEUTRALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789948 PEROXICLEAR HYDROGEN PEROXIDE SOLUTION ACCESSORIES, SOFT LENS PRODUCTS LPN BAUSCH & LOMB INCORPORATED GE16014

    Patients

    Seq Age Sex Outcome Treatment
    1