BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNK--IOL

    MDR report key: 1023609 · Received March 28, 2008

    Report

    Report Number
    1119421-2008-00200
    Event Type
    Other
    Date Received
    March 28, 2008
    Date of Event
    February 1, 2008
    Report Date
    February 28, 2008
    Manufacturer
    ALCON RESEARCH, LTD./ HUNTINGTON
    Product Code
    HQL
    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 PRODUCT WAS NOT RETURNED FOR ANALYSIS. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. ADD'L INFO WAS REQUESTED BY PHONE ON 02/28/2008, 03/03/2008, 03/04/2008, BY MAIL AND FAX ON 03/05/2008 AND BY EMAIL ON 03/06/2008 AND 03/24/2008.

    Description of Event or Problem · 1

    A SURGEON REPORTED THE HAPTIC STUCK TO THE OPTIC AND THE LENS WOULD NOT COMPLETELY UNFOLD DURING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE SURGEON COMPLETED THE PROCEDURE AND SENT THE PT HOME. WHEN THE PT RETURNED FOR A POSTOPERATIVE VISIT THE IOL HAD NOT COMPLETELY UNFOLDED AND WAS NOT CENTERED PROPERLY. THE IOL REMAINS IMPLANTED. ADD'L INFO 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 Other