BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 915908 · Received September 20, 2007

    Report

    Report Number
    1119421-2007-00385
    Event Type
    Injury
    Date Received
    September 20, 2007
    Date of Event
    January 1, 2007
    Report Date
    August 20, 2007
    Manufacturer
    ALCON LABORATORIES, INC. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P040020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR ANALYSIS. THE PRODUCT WAS DAMAGED AND THIS DAMAGE WAS NOT MENTIONED BY THE CUSTOMER. THE OPTIC WAS TORN/SPLIT/CRACKED (POSSIBLY CUT) INTO TWO PIECES. NO OTHER DAMAGE WAS OBSERVED. A LENS BENCH EVALUATION WAS NOT POSSIBLE DUE TO THE OPTIC DAMAGE ON THE RETURNED IOL. 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 ARE NO OTHER COMPLAINT REPORTS IN THIS LOT. THE MANUFACTURER'S. THIS REPORT WAS MAILED TO THE FDA ON: 09/19/2007. ADDITIONAL INFORMATION WAS REQUESTED ON 08/20/2007, 08/23/2007, 08/27/2007 AND 08/28/2007 BY PHONE AND ON 08/24/2007 BY MAIL AND FAX.

    Description of Event or Problem · 1

    A SURGEON REPORTED HIS PATIENT HAD BILATERAL INTRAOCULAR LENSES (IOL) IMPLANTED WHERE HE RECEIVED A DIFFERENT MODEL IOL IN EACH EYE. THE PATIENT COMPLAINED OF BLURRY VISION AT DISTANCE AND NEAR FOLLOWING IMPLANTATION IN HIS LEFT EYE (OS). THE PATIENT'S LEFT IOL WAS EXPLANTED AND REPLACED WITH A DIFFERENT MODEL IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON LABORATORIES, INC. / HUNTINGTON SN60D3 10703413

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR Required Intervention