BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1672472 · Received April 30, 2010

    Report

    Report Number
    1119421-2010-00531
    Event Type
    Injury
    Date Received
    April 30, 2010
    Date of Event
    January 1, 2009
    Report Date
    March 31, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; DEVICE REMAINS IMPLANTED. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ADDITIONAL INFORMATION WAS REQUESTED ON 03/31/2010, 04/02/2010, 04/06/2010, 04/16/2010, AND 04/28/2010 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONAIRE HAS NOT BEEN RECEIVED. (B) (4). (B) (4). (B) (4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "HYPEROPIC SURPRISE" (POSTOPERATIVE REFRACTION, UNEXPECTED). PRODUCT PROBLEM(S): "NONE REPORTED" (NO INFORMATION [IOL (INTRAOCULAR LENS) IMPLANT]). A SURGEON REPORTED A PATIENT WITH A HYPEROPIC SURPRISE FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE SURGEON REPORTED THE PATIENT HAD A PHOTOREFRACTIVE KERATECTOMY (PRK) PERFORMED IN 1998. THE SURGEON STATED THAT AFTER REVIEWING THE PATIENT'S FILE, HE FELT THE WRONG POWER IOL WAS IMPLANTED DUE TO THE WRONG IOL BEING ORDERED. THE SURGEON INDICATED THAT AN IOL PIGGYBACK PROCEDURE WAS PERFORMED IN A SECONDARY SURGERY. THE PATIENT WAS REPORTED TO BE DOING WELL AND PLEASED WITH HIS OUTCOME. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention