BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNK - IOL

    MDR report key: 2170079 · Received June 17, 2011

    Report

    Report Number
    1119421-2011-00754
    Event Type
    Other
    Date Received
    June 17, 2011
    Date of Event
    March 1, 2011
    Report Date
    May 20, 2011
    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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: 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. SAMPLE IS PENDING RECEIPT. ROOT CAUSE: ROOT CAUSE HAS NOT BEEN IDENTIFIED. IT WILL BE REASSESSED UPON SAMPLE RECEIPT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    FIFTEEN MONTHS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A SURGEON REPORTED HE OBSERVED A WHITE CIRCULAR FOREIGN BODY ON THE ANTERIOR SURFACE OF AN IOL. WHEN THE PATIENT HAD BEEN SEEN AT NINE MONTHS POSTOPERATIVE, THERE WAS NO PROBLEM NOTED WITH THE IOL. THE FOREIGN BODY SEEMS TO BE MOVING, FIXED TO THE LENS BUT NOT THE RHEXIS. THE FOREIGN BODY IS IN THE VISUAL AXIS OF THE PATIENT. ADDITIONAL INFORMATION 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 67 YR Other