BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 869496 · Received June 21, 2007

    Report

    Report Number
    1119421-2007-00268
    Event Type
    Other
    Date Received
    June 21, 2007
    Date of Event
    May 1, 2007
    Report Date
    May 22, 2007
    Manufacturer
    ALCON LABORATORIES, LTD. / HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THIS LOT NUMBER. ADDITIONAL INFORMATION REQUESTED 05/22/2007 AND 05/29/2007 BY PHONE, FAX AND MAIL. ADDITIONAL INFORMATION RECEIVED 05/22/2007 AND 06/08/2007 BY PHONE AND MAIL.

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A PATIENT DID NOT ACHIEVE THE DESIRED RESULT. PATIENT OUTCOME IS REPORTED AS "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON LABORATORIES, LTD. / HUNTINGTON SN60D3 958825

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other