BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEROXICLEAR HYDROGEN PEROXIDE SOLUTION

    MDR report key: 6321820 · Received February 10, 2017

    Report

    Report Number
    0001313525-2017-00249
    Event Type
    Malfunction
    Date Received
    February 10, 2017
    Date of Event
    December 22, 2016
    Report Date
    January 12, 2017
    Manufacturer
    BAUSCH & LOMB INCORPORATED
    Product Code
    LPN
    UDI-DI
    00310119038178
    PMA / PMN Number
    K132216
    Removal / Correction Number
    Z-0651-2017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT SAMPLE WAS RETURNED FOR EVALUATION AND THE RESULTS OF THE CHEMICAL TESTING PERFORMED WERE CONSISTENT WITH SHELF LIFE LIMITS.

    Additional Manufacturer Narrative · 1

    CONSUMER¿S MOTHER REPORTED THAT CONSUMER EXPERIENCED BURNING AFTER USE OF PRODUCT. CONSUMER¿S MOTHER INITIALLY BELIEVED THE EVENT TO BE CAUSED BY ALLERGIES. CONSUMER VISITED EYE CARE PRACTITIONER. INFORMATION OBTAINED FROM PRACTITIONER INDICATES PATIENT HAS A HISTORY OF GIANT PAPILLARY CONJUNCTIVITIS (GPC). PATIENT PRESENTED WITH BULBAR INJECTION, CONJUNCTIVITIS AND PAPILLAE OF THE UPPER LID TARSAL CONJUNCTIVA. THERE WAS NO INDICATION OF CORNEAL STAINING OR CORNEAL EDEMA. THE PRIMARY DIAGNOSIS WAS GPC AND THE PRACTITIONER PRESCRIBED ALREX. PRACTITIONER INDICATED THE LIKELY CAUSE OF THE EVENT WAS AN ALLERGY AND CONTACT LENS WEAR. 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 PUNCTATE STAINING OF THE CORNEA, DECREASED VISION, CORNEAL OPACITY AND EDEMA.¿ THE REPORTED SYMPTOM OF BURNING CAN BE CONSISTENT WITH THE APPLICATION OF UNNEUTRALIZED HYDROGEN PEROXIDE COMING INTO CONTACT WITH THE EYE. HOWEVER, BURNING IS ALSO A COMMON SYMPTOM ASSOCIATED WITH EYE ALLERGIES (REFERENCE: AMERICAN ACADEMY OF OPHTHALMOLOGY - EYE ALLERGY SYMPTOMS). FURTHERMORE, THE MEDICATION PRESCRIBED TO THE PATIENT, ALREX, IS INDICATED FOR TEMPORARY RELIEF OF THE SIGNS AND SYMPTOMS OF SEASONAL ALLERGIC CONJUNCTIVITIS. THE COMPLAINT SAMPLE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION.

    Description of Event or Problem · 1

    CONSUMER¿S MOTHER REPORTED THAT AFTER USE OF PRODUCT, CONSUMER EXPERIENCED BURNING. INITIALLY, CONSUMER¿S MOTHER ATTRIBUTED EVENT TO ALLERGIES. CONSUMER VISITED EYE CARE PRACTITIONER. INFORMATION OBTAINED FROM PRACTITIONER INDICATES THAT THE PATIENT HAS A HISTORY OF GIANT PAPILLARY CONJUNCTIVITIS (GPC). PRACTITIONER REPORTED THAT THE PATIENT HAD BULBAR INJECTION, CONJUNCTIVITIS AND PAPILLAE OF THE UPPER LID TARSAL CONJUNCTIVA. THERE WAS NO INDICATION OF CORNEAL STAINING OR CORNEAL EDEMA. THE PRIMARY DIAGNOSIS WAS GPC. PRACTITIONER PRESCRIBED ALREX AND INDICATED THAT THE LIKELY CAUSE OF THE EVENT WAS AN ALLERGY AND CONTACT LENS WEAR. THE SYMPTOM OF BURNING CAN BE CONSISTENT WITH THE APPLICATION OF UNNEUTRALIZED HYDROGEN PEROXIDE COMING INTO CONTACT WITH THE EYE. THE COMPLAINT COULD SUGGEST THAT THE DEVICE MALFUNCTIONED AS A RESULT OF VARIABILITY OF NEUTRALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106436 PEROXICLEAR HYDROGEN PEROXIDE SOLUTION ACCESSORIES, SOFT LENS PRODUCTS LPN BAUSCH & LOMB INCORPORATED GA16043 00310119038178

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR