BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1914389 · Received November 18, 2010

    Report

    Report Number
    1119421-2010-01272
    Event Type
    Other
    Date Received
    November 18, 2010
    Date of Event
    January 1, 2010
    Report Date
    October 19, 2010
    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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFO WAS REQUESTED ON 10/20/2010 AND 10/21/2010 BY PHONE, FAX AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 11/11/2010. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PT EXPERIENCING POSITIVE DYSPHOTOPSIA FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE SURGEON NOTED THAT ON THE TENTH POSTOPERATIVE DAY, VITREOUS WAS NOTED IN THE ANTERIOR CHAMBER COMING AROUND FROM AN INTACT CAPSULE. IN A FOLLOW UP, THE SURGEON REPORTED THE EVENT CONTINUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN60WF 10926172

    Patients

    Seq Age Sex Outcome Treatment
    1 Other USUAL POSTOPERATIVE| INTRAOPERATIVE DROPS| DUOVISC| MONARCH DELIVERY SYSTEM