BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE STEP PEROXIDE (PLATINUM) / MULTI LENS CARE SYSTEM

    MDR report key: 6230352 · Received January 6, 2017

    Report

    Report Number
    9615939-2017-00002
    Event Type
    Injury
    Date Received
    January 6, 2017
    Report Date
    December 13, 2016
    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

    Description of Event or Problem · 1

    THE PATIENT WAS TREATED FOR BACTERIAL CONJUNCTIVITIS IN BOTH EYES (OU) AND PRESCRIBED TOBRAMYCIN OU QID FOR ONE WEEK. THE PATIENT HAD MILD EPITHELIAL STAINING AND MILD LIMBAL AND BULBAR INJECTION IN THE LEFT EYE (OS) ONLY IN THE INFERIOR AND NASAL AREA. LENS USE WAS TEMPORARILY DISCONTINUED FOR 10 DAYS; THE INCIDENT IS FULLY RESOLVED AS OF (B)(6) 2016. THE EVENT DID NOT RESULT IN ANY PERMANENT CONDITIONS AND MEDICAL INTERVENTION WAS NOT REQUIRED TO PRECLUDE AND PERMANENT IMPAIRMENT.

    Description of Event or Problem · 1

    THE PATIENT WAS USING ONE STEP PEROXIDE MULTI LENS CARE SYSTEM IN COMBINATION WITH LENSES. SHE DESCRIBES REDNESS, PAIN, AND SWELLING OF HER EYES. THE PATIENT ALLEGES AN EYE INFECTION, WAS PRESCRIBED TOPICAL ANTIBIOTICS, AND HAS DISCONTINUED LENS WEAR. IT IS UNKNOWN IF THE INFECTION IS CENTRALLY LOCATED AND IF THE EVENT HAS FULLY RESOLVED. THIS EVENT IS BEING REPORTED IN ABUNDANCE OF CAUTION PER ALLEGATIONS OF AN EYE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11335 ONE STEP PEROXIDE (PLATINUM) / MULTI LENS CARE SYSTEM ONE STEP PEROXIDE (PLATINUM) / MULTI LENS CARE SYSTEM LPN SAUFLON PHARMACEUTICALS, LTD. 141148

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other