BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK--IOL

    MDR report key: 1017822 · Received March 21, 2008

    Report

    Report Number
    1119421-2008-00170
    Event Type
    Injury
    Date Received
    March 21, 2008
    Date of Event
    January 1, 2008
    Report Date
    February 21, 2008
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT HAS NOT BEEN RECEIVED FOR EVALUATION. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LENS SERIAL NUMBER, LOT NUMBER, OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ADD'L INFO WAS REQUESTED 02/28/2008, 03/03/2008, 03/04/2008 AND 03/05/2008. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    A SURGEON REPORTS THAT DURING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A HAPTIC STUCK TO THE OPTIC, RESULTING IN A BROKEN CAPSULE. A VITRECTOMY WAS PERFORMED. ADD'L INFO, INCLUDING PT STATUS, HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention