BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1530989 · Received November 6, 2009

    Report

    Report Number
    1119421-2009-01065
    Event Type
    Other
    Date Received
    November 6, 2009
    Date of Event
    September 1, 2009
    Report Date
    October 9, 2009
    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
    HI, US
    Reporter Occupation
    UNKNOWN

    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 INFO WAS REQUESTED ON 10/12/2009, 10/30/2009 AND 11/04/2009 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 10/30/2009. (B) (4). (B) (4). (B) (4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED HAVING POOR NEAR VISION FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERIES. HE ALSO REPORTED BEING SEEN BY A RETINAL SPECIALIST FOR TREATMENT OF HIS BACKGROUND DIABETIC RETINOPATHY (BDR). HE REPORTED HAVING BLEEDING IN THE BACK OF THE EYES. IN A FOLLOW-UP, THE SURGEON REPORTED THE CONSUMER EXPERIENCES CONTRAST SENSITIVITY AND POOR DISTANCE AND NEAR VISION IN LOW LIGHTING CONDITIONS. HE REPORTED THE EVENTS CONTINUE AND NOT EXPECTED TO RESOLVE DUE TO WORSENING DIABETIC RETINOPATHY. 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 SN6AD1 10873591

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other VISCOELASTIC