BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 1983067 · Received February 4, 2011

    Report

    Report Number
    1119421-2011-00070
    Event Type
    Injury
    Date Received
    February 4, 2011
    Report Date
    January 5, 2011
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADD'L INFO WAS REQUESTED ON 01/06/2011, 01/27/2011, AND 01/31/2011 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED A PT WITH BLURRY VISION WHO "COULD NOT SEE" FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE NURSE REPORTED THE SURGEON IMPLANTED A NEW LENS. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SA60AT 11025655

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention