BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1514592 · Received October 16, 2009

    Report

    Report Number
    1119421-2009-00986
    Event Type
    Other
    Date Received
    October 16, 2009
    Date of Event
    January 1, 2009
    Report Date
    September 18, 2009
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 09/21/2009, 09/22/2009, 10/12/2009, AND 10/13/2009 BY PHONE, FAX, AND MAIL. THE SURGEON IS UNABLE TO COMPLETE THE QUESTIONNAIRE. (B) (4). (B) (4). (B) (4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PATIENT WITH A DISLOCATED INTRAOCULAR LENS (IOL) FOLLOWING IOL IMPLANT SURGERY. THE SURGEON REPORTED THE PATIENT HAD A RETINAL DETACHMENT WITH SCLERAL BUCKLE TWO MONTHS FOLLOWING IOL IMPLANT SURGERY. SUBSEQUENTLY, THE IOL WAS NOTED TO BE DISLOCATED. THE SURGEON IS UNABLE TO COMPLETE THE QUESTIONNAIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60WF UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other