BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1644739 · Received March 26, 2010

    Report

    Report Number
    1119421-2010-00351
    Event Type
    Other
    Date Received
    March 26, 2010
    Date of Event
    February 23, 2010
    Report Date
    February 24, 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
    GA, 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 03/02/2010, 03/05/2010, 03/08/2010, 03/10/2010, 03/17/2010, AND 03/22/2010 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. MEDICAL RECORDS WERE RECEIVED ON 02/24/2010 AND 03/22/2010. (B) (4). (B) (4). (B) (4).

    Description of Event or Problem · 1

    ADVERSE EVENT: "PATIENT HAD LESS THAN DESIRABLE OUTCOME" (POSTOPERATIVE REFRACTION, UNEXPECTED). PRODUCT PROBLEM: "NONE REPORTED" (NO INFORMATION [IOL (INTRAOCULAR LENS) IMPLANTED]). A SURGEON REPORTED A PATIENT EXPERIENCING A LESS THAN DESIRABLE OUTCOME FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. / HUNTINGTON SN6AD1 10955098

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other SYNTHROID| BABY ASPIRIN| WELLBUTRIN