BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSEPT 1 STEP NEUTRALIZING TABLETS

    MDR report key: 4153469 · Received October 8, 2014

    Report

    Report Number
    2020664-2014-00055
    Event Type
    Injury
    Date Received
    October 8, 2014
    Report Date
    August 18, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    LPN
    PMA / PMN Number
    P850088
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION THAT WAS KNOWN BUT INADVERTENTLY NOT PROVIDED. CONCOMITANT MEDICAL PRODUCTS: CONSEPT 1-STEP HYDROGEN PEROXIDE DISINFECTING SOLUTION. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE MANUFACTURE DATE: UNKNOWN (SINCE LOT NUMBER IS UNKNOWN). ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    A DISTRIBUTOR CONTACTED OUR OFFICE TO REPORT THAT A FEMALE PATIENT EXPERIENCED OCULAR PAIN, HYPEREMIA AND CONJUNCTIVITIS AFTER USING CONSEPT ONE STEP DISINFECTING SYSTEM. THIS REPORT IS FOR THE NEUTRALIZNG TABLETS IN FOLLOW UP WITH THE PATIENT IT WAS LEARNED THAT SHE SOUGHT MEDICAL TREATMENT BECAUSE SHE EXPERIENCED REDNESS AND PAIN AFTER HER FIRST TIME USE OF THE PRODUCT. SHE WAS TOLD THAT A PIECE OF SKIN ON HER EYE WAS GOING TO BE PEELED OFF BECAUSE OF THE DISINFECTING SOLUTION. SHE WAS TREATED FOR ONE WEEK (TREATMENT WAS NOT FURTHER SPECIFIED) AND DURING THAT TIME SHE DID NOT WEAR HER CONTACT LENSES. WHEN ASKED ABOUT HER LENS CARE REGIMEN IT WAS LEARNED THAT SHE USED A RINSING SOLUTION MANUFACTURED BY ANOTHER COMPANY BUT HAS USED THIS PREVIOUSLY WITHOUT ANY DIFFICULTY. SEE COMPANION REPORT FOR CONSEPT 1 STEP DISINFECTING SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630956 CONSEPT 1 STEP NEUTRALIZING TABLETS TABLETS LPN ABBOTT MEDICAL OPTICS 09081X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other CONSEPT 1-STEP HYDROGEN PEROXIDE SOLN