BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEROXICLEAR HYDROGEN PEROXIDE SOLUTION

    MDR report key: 6115859 · Received November 20, 2016

    Report

    Report Number
    0001313525-2016-00629
    Event Type
    Injury
    Date Received
    November 20, 2016
    Date of Event
    April 13, 2016
    Report Date
    April 20, 2016
    Manufacturer
    BAUSCH & LOMB INCORPORATED
    Product Code
    LPN
    PMA / PMN Number
    K132216
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CONSUMER REPORTED MISTAKENLY USING HYDROGEN PEROXIDE SOLUTION INSTEAD OF SALINE SOLUTION WITH SCLERAL LENS. THE TESTING OF THE RETURNED LENS CASE REVEALED THAT IT DID NOT MEET ALL PRODUCT REQUIREMENTS. NOTE THAT THIS EVENT IS BEING RETROSPECTIVELY REPORTED TO FDA DUE TO THE RESULT OF A REMEDIATION ACTIVITY.

    Description of Event or Problem · 1

    CONSUMER REPORTED MISTAKENLY USING HYDROGEN PEROXIDE SOLUTION INSTEAD OF SALINE SOLUTION WITH SCLERAL LENS. MEDICAL RECORDS FROM THE EMERGENCY DEPARTMENT STATE PATIENT WAS TREATED FOR A CHEMICAL INJURY IN LEFT EYE. EYES WERE IRRIGATED DURING TRIAGE WITH 1000 ML FLUID. STAT G OXYBUPROCAINE 0.4% WAS GIVEN FOLLOWING IRRIGATION PH O/A 8.0. PATIENT WAS PRESCRIBED CHLORAMPHENICOL 1% OINTMENT/GEL, CYCLOPENTOLATE HYDROCHLORIDE DROPS, PREDSOL DROPS AND DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766705 PEROXICLEAR HYDROGEN PEROXIDE SOLUTION ACCESSORIES, SOFT LENS PRODUCTS LPN BAUSCH & LOMB INCORPORATED MB0246

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other