BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 927253 · Received October 12, 2007

    Report

    Report Number
    1119421-2007-00412
    Event Type
    Injury
    Date Received
    October 12, 2007
    Date of Event
    January 1, 2007
    Report Date
    September 12, 2007
    Manufacturer
    ALCON LABORATORIES, INC./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR ANALYSIS. ONE HAPTIC WAS BROKEN-GUSSET AREA (NOT RETURNED); THE OTHER HAPTIC WAS BENT-DISTAL AREA. THE OPTIC WAS SCRATCHED AND TORN/SPLIT/CRACKED AND A PORTION OF THE CENTRAL OPTIC ZONE WAS NOT RETURNED. A LENS BENCH TEST COULD NOT BE PERFORMED DUE TO OPTIC DAMAGE. WHILE WE ARE UNABLE TO DETERMINE THE ORIGIN OF THE DAMAGE, OUR OBSERVATION REASONABLY SUGGESTS THAT IT IS NOT MANUFACTURING RELATED. PRODUCT HISTORY RECORDS WERE REVIEWED AND ALL DOCUMENTS INDICATE THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADD'L INFORMATION WAS REQUESTED ON 09/13/2007 AND 09/14/2007 BY MAIL, FAX AND PHONE. ADD'L INFO WAS RECEIVED 09/13/2007, 09/14/2007 AND 10/08/2007 BY PHONE AND FAX.

    Description of Event or Problem · 1

    A SURGEON REPORTS THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A PT WAS DISSATISFIED WITH HER VISION. THE LENS WAS EXCHANGED WITH A DIFFERENT MODEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON LABORATORIES, INC./HUNTINGTON SN60D3 10605947

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention