BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONSEPT 1-STEP DISINFECTING SOLUTION, DEV. 1

    MDR report key: 3099558 · Received April 29, 2013

    Report

    Report Number
    3004178847-2013-00005
    Event Type
    Other
    Date Received
    April 29, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 29, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS INC.
    Product Code
    LPN
    PMA / PMN Number
    P850088
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CHEMISTRY EVALUATIONS OF THE ACTUAL PRODUCT USED BY THE CONSUMER WERE PERFORMED; ALL RESULTS WERE WITHIN SPECIFICATIONS. PRELIMINARY TESTING PERFORMED AT (B)(4) QUALITY CONTROL LAB. ADDITIONAL PRODUCT ANALYSIS (MFG RECORD REVIEW, RETURNED-CHEMISTRY TESTING, AND RETAIN-MICROBIOLOGICAL TESTING) WILL BE PERFORMED AT MFG SITE(S). CHEMISTRY TESTING OF A RETAINED UNIT OF THE REPORTED LOT WAS COMPLETED. THE SAMPLE MET THE FOLLOWING SPECIFICATIONS: APPEARANCE, PH, TABLETS NEUTRALIZATION AND DISSOLUTION OF 9081X AND HYDROGEN PEROXIDE ASSAY. ALL AVAILABLE PERTINENT INFO HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    OUR OFFICE IN (B)(6) RECEIVED A REPORT (B)(6) 2013, FROM A WHOLESALE CUSTOMER. THEY REPORTED THAT A FEMALE PT IN HER TWENTIES DISINFECTED / NEUTRALIZED HER LENSES WITH CONSEPT 1-STEP, LEFT THEM IN THE NEUTRALIZED SOLUTION OVER 7 DAYS, THEN WORE LENSES. AFTER WHICH, THE PT EXPERIENCED A CORNEAL ULCER (EYE UNK). F/U WITH THE PT ON (B)(6) 2013, INDICATED THAT WHILE SHE INITIALLY STATED SHE SOAKED HER BIOFINITY CONTACT LENSES IN SOLUTION FOR OVER 7 DAYS AFTER DISINFECTION, SHE REVISED THAT TIME PERIOD TO 3 OF 4 DAYS. THE PT ALSO REPORTED THAT HER EYE CONDITION SEEMED TO BE RECOVERED A LITTLE, BUT SHE STILL HAD NOT VISITED AN EYE CLINIC. THE PT REPORTED VISITING AN EYE CLINIC (DATE AND TREATMENT UNK) AND WAS DIAGNOSED WITH A CORNEAL ULCER. THE PT DECIDED TO CHANGE THE TYPE OF LENS SHE WEARS TO A DAILY DISPOSABLE LENS. SEE ASSOCIATED REPORT, DEVICE 2: 2020664-2013-10002.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184682 CONSEPT 1-STEP DISINFECTING SOLUTION, DEV. 1 LPN ABBOTT MEDICAL OPTICS INC. ZK00584

    Patients

    Seq Age Sex Outcome Treatment
    1 Other BIOFINITY CONTACT LENSES| CONSEPT 1-STEP NEUTRALIZING TABLETS