BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1153245 · Received September 5, 2008

    Report

    Report Number
    1119421-2008-00673
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    June 10, 2008
    Report Date
    August 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. 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 VIA FAX AND MAIL ON 08/11/2008 AND VIA PHONE ON 08/18/2008 AND 08/25/2008. A COMPLETED QUESTIONNAIRE WAS RECEIVED. THIS REPORT WAS MAILED TO FDA ON: 09/05/2008.

    Description of Event or Problem · 1

    A NURSE REPORTED THE INTRAOCULAR LENS (IOL) DID NOT WORK FOR THIS PATIENT FOLLOWING IOL IMPLANT SURGERY. SHE STATED THE SURGEON FELT IT WAS A "PATIENT ISSUE". THE IOL WAS REMOVED AND REPLACED WITH A DIFFERENT LENS MODEL, IN A SECOND SURGERY. THE SURGEON REPORTED THE OUTCOME OF THE EVENT FOR THE PATIENT AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. / HUNTINGTON SN6AD3 10757533

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention