BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE STEP PEROXIDE (PLATINUM) / MULTI LENS CARE SYSTEM

    MDR report key: 6223842 · Received January 4, 2017

    Report

    Report Number
    9615939-2017-00001
    Event Type
    Injury
    Date Received
    January 4, 2017
    Report Date
    December 8, 2016
    Manufacturer
    SUAFLON PHARMACUETICALS, LTD.
    Product Code
    LPN
    PMA / PMN Number
    K010559
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BMR FOR BATCH 142474 WAS REVIEWED WITH NO ISSUES RECORDED AND ALL PRODUCT TESTING WERE WITHIN SPECIFICATION. THE ASSOCIATION BETWEEN COOPERVISION SOLUTION AND THE EVENT IS UNCONFIRMED.

    Description of Event or Problem · 1

    THE PATIENT ALLEGEDLY SUFFERED FROM 3RD DEGREE BURNS TO THE LEFT (OS) CORNEA. TREATMENT IS UNKNOWN, HOWEVER THE CORNEA IS RECOVERING AND VISUAL ACUITY IS DOWN TO 6/10. IT IS UNKNOWN IF THIS EVENT HAS FULLY RESOLVED. IN THE ABSENCE OF MEDICAL INFORMATION, THIS EVENT IS BEING REPORTED IN ABUNDANCE OF CAUTION BASED ON THE SEVERITY OF THE ALLEGATION OF A 3RD DEGREE BURN TO THE CORNEA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5935 ONE STEP PEROXIDE (PLATINUM) / MULTI LENS CARE SYSTEM ONE STEP PEROXIDE (PLATINUM) / MULTI LENS CARE SYSTEM LPN SUAFLON PHARMACUETICALS, LTD. 142474

    Patients

    Seq Age Sex Outcome Treatment
    1 Other