BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNK -- IOL

    MDR report key: 1380600 · Received May 11, 2009

    Report

    Report Number
    1119421-2009-00463
    Event Type
    Other
    Date Received
    May 11, 2009
    Date of Event
    January 1, 2009
    Report Date
    April 11, 2009
    Manufacturer
    ALCON MANUFACTURING, LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE 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 MFG DOCUMENTATION. ADD'L INFO WAS REQUESTED ON 04/15/2009, 04/21/2009, 04/27/2009, 04/29/2009, AND 05/04/2009 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONAIRE HAS NOT BEEN RECEIVED. THIS REPORT WAS MAILED TO FDA ON: 05/11/2009.

    Description of Event or Problem · 1

    A SURGEON REPORTED A PT WITH AN UNEXPECTED POSTOPERATIVE REFRACTION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. ADD'L INFO HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other