BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSEPT 1-STEP DISINFECTING SOLUTION

    MDR report key: 3954715 · Received July 18, 2014

    Report

    Report Number
    3004178847-2014-00006
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    April 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS INC.
    Product Code
    LPN
    PMA / PMN Number
    P850088
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UNSPECIFIED DAMAGE TO THE EYE. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT FROM A FEMALE PATIENT WHO REPORTED SHE EXPERIENCED OCULAR REDNESS WHILE USING CONSEPT 1-STEP DISINFECTING/NEUTRALIZING FOR LESS THAN ONE MONTH. SHE SOUGH MEDICAL TREATMENT AND WAS TOLD HER EYES WERE "DAMAGED." SHE WAS PRESCRIBED CRAVIT OPHTHALMIC SOLUTION (LEVOFLOXACIN 0.5% AND HYALURONATE SODIUM) AND DISCONTINUED LENS WEAR FOR AWHILE. SHE STATED THAT HER DOCTOR DID NOT KNOW THE CAUSE OF THE OCULAR REDNESS. AFTER A MONTH SHE THOUGHT HER SYMPTOMS RESOLVED SO SHE TRIED THE PRODUCT AGAIN AND THE REDNESS RETURNED. AFTER REVIEWING HOW TO USE THE PRODUCT WITH THE PATIENT IT WAS THOUGHT THAT PERHAPS SOME HYDROGEN PEROXIDE FROM THE LENS CASE TOUCHED THE EYE. SEE COMPANION FILE 2020664-2014-10004 FOR NEUTRALIZING TABLETS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422547 CONSEPT 1-STEP DISINFECTING SOLUTION HYDROGEN PEROXIDE DISINFECTING SOLUTION LPN ABBOTT MEDICAL OPTICS INC. ZP00273

    Patients

    Seq Age Sex Outcome Treatment
    1 Other CONSEPT 1-STEP NEUTRALIZING TABLETS