BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE STEP PEROXIDE (PLATINUM)

    MDR report key: 5043395 · Received August 31, 2015

    Report

    Report Number
    9615939-2015-01006
    Event Type
    Injury
    Date Received
    August 31, 2015
    Date of Event
    July 30, 2015
    Report Date
    August 27, 2015
    Manufacturer
    SAUFLON PHARMACEUTICALS, LTD
    Product Code
    LPN
    PMA / PMN Number
    K010559
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS CANNOT BE PERFORMED. NO LENSES WERE RETURNED FOR EVALUATION AND LOT NUMBER IS UNKNOWN. THE ASSOCIATION BETWEEN COOPERVISION LENSES AND THE EVENT IS UNCONFIRMED. THE COMPLAINT IS UNCONFIRMED. THE ASSOCIATION BETWEEN COOPERVISION LENSES AND THE INCIDENT IS UNCONFIRMED.

    Description of Event or Problem · 1

    THE MANUFACTURER WAS INFORMED BY A THIRD PARTY REPRESENTING A CVI BUSINESS PARTNER THAT A CONSUMER HAD ALLEGEDLY EXPERIENCED A CHEMICAL BURN TO THEIR CORNEA AFTER USE OF A CVI SOLUTION. THE CONSUMER WENT TO A HOSPITAL AND RECEIVED MEDICAL TREATMENT FOR THE CHEMICAL BURNS. GOOD FAITH EFFORTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION WITHOUT RESULTS. IN AN ABUNDANCE OF CAUTION THIS EVENT IS BEING REPORTED BASED ON THE ALLEGED DIAGNOSIS (CHEMICAL BURNS TO THE CORNEA) AND PERMANENT INJURY IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575070 ONE STEP PEROXIDE (PLATINUM) MULTI LENS CARE SYSTEM LPN SAUFLON PHARMACEUTICALS, LTD PT3MP355WD1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other