BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONSEPT 1 STEP DISINFECTING SOLUTION

    MDR report key: 2956414 · Received January 30, 2013

    Report

    Report Number
    3004178847-2013-00001
    Event Type
    Other
    Date Received
    January 30, 2013
    Report Date
    December 13, 2012
    Manufacturer
    ABBOTT MEDICAL OPTICS INC.
    Product Code
    LPN
    PMA / PMN Number
    P8500088
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL PERTINENT INFO AVAILABLE TO THE MFR HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    OUR OFFICE IN (B)(4) RECEIVED A REPORT FROM A FEMALE PT WHO MISUSED CONSEPT 1 STEP DISINFECTING SOLUTION. THE REPORT STATES THAT THE PT DID NOT USE THE NEUTRALIZING TABLETS PRIOR TO INSERTING HER CONTACT LENSES. SHE EXPERIENCED OCULAR PAIN AND SOUGHT MEDICAL TREATMENT. SHE WAS GIVEN UNSPECIFIED EYE DROPS AND REPORTED SHE HAD A CORNEAL SCAR. THE REPORTER DECLINED TO PROVIDE HER CONTACT INFO OR ALLOW US TO FOLLOW UP WITH HER HEALTH CARE PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40168 CONSEPT 1 STEP DISINFECTING SOLUTION LPN ABBOTT MEDICAL OPTICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other