BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 1080728 · Received July 23, 2008

    Report

    Report Number
    1119421-2008-00537
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    January 1, 2008
    Report Date
    June 23, 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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR ANALYSIS, AND THE REPORTED COMPLAINT WAS NOT OBSERVED. THE LENS OPTIC WAS NOT CLOUDY. THE PRODUCT WAS DAMAGED. HAPTICS WERE BENT IN THE GUSSET AREA. THE OPTIC WAS SCRATCHED AND CRACKED. WHILE WE ARE UNABLE TO DETERMINE THE ORIGIN OF THE DAMAGE, OUR OBSERVATION REASONABLY SUGGESTS THAT IT IS NOT MANUFACTURING RELATED. THE OPTICAL RESOLUTION AND FOCAL LENGTH WERE ACCEPTABLE FOR A 13.0 DIOPTER. PRODUCT HISTORY RECORDS WERE REVIEWED AND ALL DOCUMENTS INDICATE THE PRODUCT MET RELEASE CRITERIA. THERE ARE NO OTHER COMPLAINTS REPORTED IN THIS LOT NUMBER. ADDITIONAL INFO WAS REQUESTED. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. THIS REPORT WAS MAILED TO FDA ON: 07/23/2008.

    Description of Event or Problem · 1

    A SURGEON REPORTED HE EXPLANTED AN INTRAOCULAR LENS (IOL) APPROX NINE YEARS FOLLOWING IOL IMPLANT SURGERY. THE SURGEON STATED THE IOL HAD BECOME CLOUDY. ANOTHER IOL WAS IMPLANTED. THE PT WAS REPORTED AS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD/HUNTINGTON MA60BM 573169

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention