BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 1130869 · Received August 21, 2008

    Report

    Report Number
    1119421-2008-00618
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    June 10, 2008
    Report Date
    June 13, 2008
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR ANALYSIS. ONE HAPTIC WAS BENT IN THE GUSSET AND DISTAL REGIONS. WHILE WE ARE UNABLE TO DETERMINE THE ORIGIN OF THE DAMAGE, OUR OBSERVATION REASONABLY SUGGESTS THAT IT IS NOT MANUFACTURING RELATED. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THIS LOT NUMBER. ADD'L INFO WAS REQUESTED 6/16/2008, 7/3/2008 AND 7/17/2008 BY MAIL, FAX AND PHONE. A COMPLETED QUESTIONNAIRE WAS RECEIVED. THIS REPORT WAS MAILED TO FDA ON: 8/21/2008.

    Description of Event or Problem · 1

    A NURSE REPORTS AN ENLARGEMENT OF THE INCISION WAS REQUIRED TO ACCOMMODATE REMOVAL OF THE INTRAOCULAR LENS (IOL) WHEN A HAPTIC WOULD NOT SITUATE PROPERLY FOLLOWING IOL INSERTION. ADD'L INFO WAS PROVIDED REPORTING THE PT ALSO HAD A VITRECTOMY. THE PT OUTCOME WAS REPORTED AS "EXCELLENT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON MA60AC 117575

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention