BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1813635 · Received August 13, 2010

    Report

    Report Number
    1119421-2010-00899
    Event Type
    Other
    Date Received
    August 13, 2010
    Date of Event
    June 1, 2010
    Report Date
    July 16, 2010
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 07/19/2010 AND 08/09/2010 BY PHONE, FAX, AND MAIL. MEDICAL RECORDS WERE RECEIVED ON 08/04/2010. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "REFRACTIVE SURPRISE" (POSTOPERATIVE REFRACTION, UNEXPECTED) PRODUCT PROBLEM(S): "NO INFORMATION" (NO INFORMATION [IOL (INTRAOCULAR LENS) IMPLANT]). A SURGEON REPORTED A PATIENT WITH A REFRACTIVE SURPRISE FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other