BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNK -- IOL

    MDR report key: 2023672 · Received March 3, 2011

    Report

    Report Number
    1119421-2011-00263
    Event Type
    Other
    Date Received
    March 3, 2011
    Date of Event
    January 1, 2011
    Report Date
    February 9, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVAL: 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. ROOT CAUSE: NO SERIAL/LOT NUMBER OR SAMPLE WAS PROVIDED BY THE CUSTOMER. THE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. ACTION TAKEN: NO FURTHER ACTION IS WARRANTED AT THIS TIME. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED AND FURTHER ACTION WILL BE INITIATED WHEN DEEMED NECESSARY BY THE APPROPRIATE RESPONSIBLE MANAGEMENT PERSONNEL. ADDITIONAL INFO WAS REQUESTED 02/11/2011 AND 03/01/2011 BY FAX, MAIL AND PHONE. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED GLISTENINGS IN SIX PTS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE PTS HAVE PRESENTED WITH VARIOUS VISION ISSUES, REPORTING BLURRY OR CLOUDY VISION. THE SURGEON REPORTS THAT "GLINTS" ARE SEEN IN THE LENS, NOT ON THE SURFACE. THIS PT WAS REPORTED TO HAVE BLURRY VISION AND WAS REFERRED BY THE OPTOMETRIST FOR A YAG, BUT THE CAPSULE WAS CLEAR. ADDITIONAL INFO HAS BEEN REQUESTED. THERE ARE SIX MEDICAL DEVICE REPORTS ASSOCIATED WITH THESE EVENTS. THIS IS FOR PT NUMBER SIX.

    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