BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1053286 · Received May 28, 2008

    Report

    Report Number
    1119421-2008-00374
    Event Type
    Injury
    Date Received
    May 28, 2008
    Date of Event
    January 1, 2008
    Report Date
    April 28, 2008
    Manufacturer
    ALCON MANUFACTURING, LTD./HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. ADD'L INFO WAS REQUESTED ON 4/29/2008 BY PHONE, ON 4/30/2008 BY FAX AND MAIL AND ON 5/14/2008 BY PHONE. ADD'L INFO WAS RECEIVED. THIS REPORT WAS MAILED TO FDA ON: 5/28/2008.

    Description of Event or Problem · 1

    A FACILITY REPORTED A PT HAD GOOD NEAR VISION, BUT COULD NOT SEE AT A DISTANCE FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE SURGEON PERFORMED YAG AND LASIK SURGERIES IN AN ATTEMPT TO IMPROVE THE PT'S DISTANT VISION. THE OUTCOME FOR THIS PT IS +0.50 WITH GOOD DISTANT VISION. HOWEVER, NOW SHE CANNOT READ AT NEAR DISTANCES. ADD'L INFO RECEIVED FROM THE SURGEON STATED THE PT HAS A LARGE, DECENTERED PUPIL (INFERIOR-NASAL) AND THE PT'S PUPIL IS NOT LINED UP WITH THE OPTIC OF THE IOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON MANUFACTURING, LTD./HUNTINGTON NI 10709954

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention