BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE EASY-RUB

    MDR report key: 4153617 · Received October 8, 2014

    Report

    Report Number
    3004537773-2014-00010
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    February 10, 2014
    Report Date
    July 3, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    LPN
    PMA / PMN Number
    K014202
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT AND EXPIRATION DATE ARE UNKNOWN. INITIAL REPORTER TELEPHONE NUMBER: (B)(6). (B)(4). ALTERNATIVE REPORT IDENTIFICATION NUMBER (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    WHILE REVIEWING THE FDA MAUDE DATABASE A REPORT WAS FOUND INVOLVING A (B)(6) YEAR OLD FEMALE PATIENT WHO EXPERIENCED A CORNEAL ULCER, CORNEAL SCAR, OCULAR IRRITATION, AND ITCHING WHILE INCLUDING COMPLETE MULTIPURPOSE SOLUTION TO CARE FOR HER AIR OPTIX AQUA SOFT CONTACT LENSES. THE REPORT WAS SUBMITTED TO FDA BY THE CONTACT LENS MANUFACTURER FOR THE CONTACT LENSES (3006186389-2014-00019). THE REPORTER ASSESSED THE CAUSALITY ATTRIBUTABLE TO THE CONTACT LENSES AS POSSIBLE AND PROBABLE. COMPLETE MULTIPURPOSE SOLUTION WAS NOTED AS A CONCOMITANT PRODUCT ON THE 3500A. FOLLOW UP INFORMATION FROM THE OPTICIAN INDICTED THE PATIENT FOLLOWED THE INSTRUCTIONS FOR USE, DID NOT USE TAP WATER, WORE HER LENSES ON A DAILY WEAR BASIS (NOT EXTENDED WEAR).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631661 COMPLETE EASY-RUB SOLUTIONS LPN ABBOTT MEDICAL OPTICS 09424X UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention ALCON AIR OPTIX CONTACT LENSES