BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1221254 · Received November 5, 2008

    Report

    Report Number
    1119421-2008-00875
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    October 23, 2008
    Report Date
    October 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
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. THERE HAVE BEEN NO OTHER SIMILAR COMPLAINTS REPORTED IN THE LOT NUMBER. ADD'L INFO WAS REQUESTED ON 10/07/2008 BY FAX AND MAIL. A COMPLETED QUESTIONNAIRE WAS REC'D ON 10/08/2008.

    Description of Event or Problem · 1

    A SURGEON REPORTED HAVING A PT WITH AN UNEXPECTED POSTOPERATIVE REFRACTION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE LENS WAS REPLACED WITH THE SAME MODEL. IN A F/U, THE SURGEON STATES THAT "THERE IS NO PROD ISSUE". BOTH SURGEON AND PT ARE EXTREMELY SATISFIED WITH THE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. / HUNTINGTON SN6AD3 10802103

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention