BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONSEPT 1-STEP NEUTRALIZING TABLETS, DEV. 2

    MDR report key: 3099557 · Received April 29, 2013

    Report

    Report Number
    2020664-2013-10002
    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

    EVAL (CONCLUSIONS): LOT NUMBER OF SOLUTION USED BY PT IS UNK. IT IS UNK IF THE DEVICE FAILED TO MEET SPECIFICATIONS AS WE HAVE NOT RECEIVED THE COMPLAINT SAMPLE FOR ANALYSIS NOR HAVE WE RECEIVED AN IDENTIFYING LOT NUMBER TO PERFORM PRODUCT INVESTIGATION. THE DEVICE WAS MOST PROBABLY BEING USED FOR TREATMENT, AS THIS TYPE OF DEVICE IS NOT TYPICALLY USED FOR DIAGNOSTICS. THE RELATIONSHIP, IF ANY, OF THE DEVICE TO THE REPORTED INCIDENT / ADVERSE EVENT IS UNK. THE COMPLAINANT REPORTED AN ASSOCIATION BETWEEN THE AMO DEVICE AND THE REPORTED EVENT. HOWEVER, BECAUSE WE HAVE NOT RECEIVED THE COMPLAINT SAMPLE FOR ANALYSIS, NOR HAVE WE RECEIVED AN IDENTIFYING LOT NUMBER TO GUIDE OUR TESTING, WE HAVE BEEN UNABLE TO DETERMINE THE RELATIONSHIP. ROOT CAUSE HAS NOT BEEN ESTABLISHED. 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 1: 3004178847-2013-00005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184791 CONSEPT 1-STEP NEUTRALIZING TABLETS, DEV. 2 LPN ABBOTT MEDICAL OPTICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other BIOFINITY CONTACT LENSES| CONSEPT 1-STEP DISINFECTING SOLUTION