BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED LENS CUP FOR H2O2 DISINF SYS

    MDR report key: 1592965 · Received January 28, 2010

    Report

    Report Number
    2020664-2009-00085
    Event Type
    Malfunction
    Date Received
    January 28, 2010
    Report Date
    November 10, 2009
    Manufacturer
    ABBOTT MEDICAL OPTICS, INC.
    Product Code
    LPN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    OUR OFFICE IN (B) (4) REPORTED A FEMALE CONSUMER INDICATED HER LENS CUP USED FOR A HYDROGEN PEROXIDE DISINFECTION SYSTEM DEVELOPED BROWN SPOTS ON THE INSIDE OF THE CAP AFTER USING THE PRODUCT FOR ABOUT 2 MONTHS. IN F/U, IT WAS LEARNED THAT SHE DID NOT FOLLOW LABELED INSTRUCTIONS FOR WEEKLY AND DAILY DISINFECTION OF THE CUP. THE PT DID NOT EXPERIENCE ANY ADVERSE REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTED LENS CUP FOR H2O2 DISINF SYS LPN ABBOTT MEDICAL OPTICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 OXYSEPT 1-STEP DISINFECTING SOLUTION| OXYSEPT 1-STEP NEUTRALIZING TABLETS