BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE 2 BRAND CONTACT LENSES

    MDR report key: 1760584 · Received July 14, 2010

    Report

    Report Number
    1033553-2010-00044
    Event Type
    Injury
    Date Received
    July 14, 2010
    Report Date
    July 14, 2010
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    N18033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. NO EVAL WILL BE PERFORMED.

    Description of Event or Problem · 1

    ON 06/22/2010, A PT REPORTED THAT IN 2000 OR 2001, THE PT WAS DIAGNOSED AND TREATED FOR AN ULCER WHILE WEARING ACUVUE 2 BRAND CONTACT LENSES. THE PT COULD NOT CONFIRM WHICH EYE WAS INVOLVED. THE PT REPORTED BEING "GIVEN SOME KIND OF CHEMICAL DROP" AND AN OINTMENT TO TREAT THE ULCER AND INSTRUCTED TO DISCONTINUE CONTACT LENS WEAR FOR "ABOUT 2 WEEKS." THE PT COULD NOT REMEMBER THE NAME OR CONTACT DETAILS FOR THE TREATING DOCTOR. THE LOT NUMBER OF THE PRODUCT IN QUESTION IS UNK. THE PRODUCT IN QUESTION HAS BEEN DISCARDED AND IS NOT AVAILABLE FOR EVAL. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME AND NO ADDITIONAL INFO IS EXPECTED TO BE RECEIVED FROM THE PT. WILL REPORT ANY ADDITIONAL INFO WITHIN 30 DAYS OF RECEIPT. MDR REPORTABLE EVENTS ARE REVIEWED IN QUARTERLY MANAGEMENT REVIEW MEETINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUVUE 2 BRAND CONTACT LENSES SOFT CONTACT LENSES LPL VISTAKON NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention