BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONSEPT GORETEX CUP

    MDR report key: 1466309 · Received September 2, 2009

    Report

    Report Number
    2020664-2009-00051
    Event Type
    Other
    Date Received
    September 2, 2009
    Date of Event
    April 1, 2009
    Report Date
    August 7, 2009
    Manufacturer
    ABBOTT MEDICAL OPTICS, INC.
    Product Code
    LPN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE HAS NOT BEEN ESTABLISHED.

    Description of Event or Problem · 1

    OUR OFFICE IN (B) (4) REPORTED A PT EXPERIENCED OCULAR HYPEREMIA ABOUT 6 MONTHS AGO WHEN THEY CHANGED THEIR LENS CARE REGIMEN TO INCLUDE CONSEPT 1-STEP SYSTEM. THEY WERE INITIALLY TOLD BY AN OPHTHALMOLOGIST THAT THE CAUSE OF THE REDNESS WAS UNK, BUT IT MAY BE DUE TO DRYNESS. THEY SAW ANOTHER PHYSICIAN WHEN THE HYPEREMIA RECURRED AND WAS TOLD IT WAS "SOMETHING LIKE KERATITIS" AND THAT FUNGUS OR BACTERIA WERE PRESENT. NO TREATMENT DETAILS WERE PROVIDED. WHEN THE HYPEREMIA RESOLVED, THEY RESUMED LENS WEAR, USING CONSEPT 1 STEP AND AGAIN THE HYPEREMIA RETURNED. ACCORDING TO THE 3RD PHYSICIAN, NO BACTERIA OR FUNGUS WERE OBSERVED. SEE ALSO MDRS 2020664-2009-00049 (DEVICE 1) AND 2020664-2009-00050 (DEVICE 2). THIS IS THE SAME REPORTER AS MDRS 2020664-2009-00040, 2020664-2009-00045, AND 2020664-2009-00046 PROVIDING ADD'L LOT NUMBERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSEPT GORETEX CUP LPN ABBOTT MEDICAL OPTICS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other