BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1634821 · Received March 17, 2010

    Report

    Report Number
    1119421-2010-00283
    Event Type
    Injury
    Date Received
    March 17, 2010
    Date of Event
    February 15, 2010
    Report Date
    February 15, 2010
    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 THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED ON 02/25/2010 AND 03/08/2010 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 03/08/2010. MEDICAL RECORDS WERE RECEIVED ON 02/15/2010. (B) (4) (B) (4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PATIENT WITH A HYPEROPIC SURPRISE FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE SURGEON REPORTED THE PATIENT HAD 1-2 PLUS MICROCYSTIC EDEMA NOTED ON THE FIRST POSTOPERATIVE DAY WHICH RESOLVED WITHOUT TREATMENT. IN THE MEDICAL RECORDS, THE INTRAOCULAR PRESSURE (IOP) WAS ELEVATED ON THE FIRST POSTOPERATIVE DAY. A PARACENTESIS WAS PERFORMED AND THE IOP RETURNED TO NORMAL. THE PATIENT WAS TREATED WITH MEDICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. / HUNTINGTON SN6AD1 10939942

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention