BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1120771 · Received August 15, 2008

    Report

    Report Number
    1119421-2008-00604
    Event Type
    Other
    Date Received
    August 15, 2008
    Date of Event
    April 16, 2007
    Report Date
    July 14, 2008
    Manufacturer
    ALCON RESEARCH, 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 THIS LOT NUMBER. ADD'L INFO WAS REQUESTED ON 07/14/2008, 07/16/2008, 07/18/2008, 07/22/2008, 07/24/2008, 07/28/2008 AND 08/05/2008 BY EMAIL, PHONE FAX AND MAIL. A COMPLETED QUESTIONNAIRE HAS BEEN RECEIVED.

    Description of Event or Problem · 1

    A SURGEON REPORTS A PT HAD PROLONGED CORNEAL EDEMA AND COMPLAINED OF BLURRY VISION IN HIS LEFT EYE FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. A YAG LASER SURGERY WAS PERFORMED AND THE PT REPORTED MINIMAL IMPROVEMENT IN HIS VISION FOLLOWING THIS PROCEDURE. THE SURGEON HAS PRESCRIBED GLASSES FOR THE PT. THE PT STATED THE EYEGLASSES HAVE HELPED. IN A FOLLOW UP, THE SURGEON REPORTS THE OUTCOME OF THE EVENT FOR THE PT AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD./HUNTINGTON SA60D3 155839

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other VIGAMOX| PRED FORTE