BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEROXICLEAR HYDROGEN PEROXIDE SOLUTION

    MDR report key: 6111592 · Received November 17, 2016

    Report

    Report Number
    0001313525-2016-00607
    Event Type
    Injury
    Date Received
    November 17, 2016
    Date of Event
    October 7, 2016
    Report Date
    October 24, 2016
    Manufacturer
    BAUSCH & LOMB INCORPORATED
    Product Code
    LPN
    PMA / PMN Number
    K132216
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT

    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. AN ASSESSMENT OF THE CASE WAS COMPLETED BY BAUSCH + LOMB MEDICAL PERSONNEL. CONSUMER'S SYMPTOMS OF IRRITATION ARE CONSISTENT WITH GPC. THE CONDITION IS UNDER THE UPPER EYELID; IT DOES NOT AFFECT THE CORNEA OR BULBAR CONJUNCTIVA. THE IRRITATION REPORT IS UNLIKELY RELATED TO RESIDUAL PEROXIDE. THE DIAGNOSIS OF GPC MAY BE RELATED TO FACTORS UNRELATED TO THE DEVICE. BASED ON AVAILABLE INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED AND NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    CONSUMER REPORTED VISITING EYE CARE PRACTITIONER FOR ANNUAL EXAM. CONSUMER REPORTED DISCONTINUING LENS WEAR A WEEK PRIOR TO THE EXAM DUE TO IRRITATION. AT THE EXAM, CONSUMER REPORTED THE DOCTOR DIAGNOSED GIANT PAPILLARY CONJUNCTIVITIS (GPC). THE CONSUMER REPORTED THAT THE DOCTOR PRESCRIBED MEDICATION FOR THE CONDITION. THE DOCTOR¿S OFFICE REPRESENTATIVE CONFIRMED THE DIAGNOSIS OF GPC IN PATIENT¿S LEFT EYE AND INDICATED THAT FLUOROMETHOLONE 1% WAS PRESCRIBED FOR STATED LEFT EYE. THE CONSUMER ALSO REPORTED USING PAZEO FOR THE RIGHT EYE. THE DOCTOR¿S OFFICE REPRESENTATIVE STATED THAT THERE WAS NO DIAGNOSIS FOR THE RIGHT EYE. THE CONSUMER REPORTED FULFILLING THE RECOMMENDED TREATMENT PERIOD, REPORTS EYES TO BE RECOVERED, AND HAS RETURNED TO LENSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761126 PEROXICLEAR HYDROGEN PEROXIDE SOLUTION ACCESSORIES, SOFT LENS PRODUCTS LPN BAUSCH & LOMB INCORPORATED GE16001

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other