BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1070716 · Received July 3, 2008

    Report

    Report Number
    1119421-2008-00491
    Event Type
    Other
    Date Received
    July 3, 2008
    Date of Event
    January 1, 2008
    Report Date
    June 6, 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
    MI, 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. ADDITIONAL INFORMATION WAS REQUESTED 06/09/2008 AND 06/11/2008 BY FAX, MAIL AND PHONE. PATIENT RECORDS AND A COMPLETED QUESTIONNAIRE WERE RECEIVED. THIS IS REPORT WAS MAILED TO FDA ON: 07/03/2008.

    Description of Event or Problem · 1

    A SURGEON REPORTS THAT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A PATIENT REPORTED CONSTANT GLARE AT DISTANCE AND NEAR, BOTH NIGHT AND DAY. THE PATIENT ALSO REPORTED BLURRY VISION, TROUBLE FOCUSING, AND HALOS AROUND LIGHTS. THE PATIENT REPORTS HAVING A "BRAIN DISCONNECT" THAT DOES NOT ALLOW HIS BRAIN RECOGNIZE WHAT AN OBJECT IS. SLIT LAMP EXAMINATION REVEALED TRACE CLOUDY POSTERIOR CAPSULES BILATERALLY. THE PATIENT IS BEING TREATED WITH MEDICATIONS. THE SURGEON REPORTS OUTCOME OF EVENT FOR THIS PATIENT AS "EXCELLENT". THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. / HUNTINGTON SN6AD3 10745198

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other RESTASIS| ALPHAGAN P