BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS MULTIFOCAL

    MDR report key: 1871942 · Received October 16, 2010

    Report

    Report Number
    2648035-2010-00194
    Event Type
    Injury
    Date Received
    October 16, 2010
    Date of Event
    August 11, 2010
    Report Date
    September 21, 2010
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P080010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS WAS RECEIVED FOR ANALYSIS AND INSPECTED UNDER ILLUMINATED 10X MAGNIFICATION. RESULTS SHOWED AN IOL CUT IN HALF ACROSS THE HAPTIC WITH ONE DETACHED HAPTIC. DAMAGE TO THE LENS OCCURRED DURING THE EXPLANT PROCEDURE AND IS NOT RELATED TO THE EVENT. HALOS AND/OR GLARE ARE A KNOWN AND LABELED POSSIBLE SIDE EFFECT OF ALL MULTIFOCAL LENS IMPLANTS. THERE WAS NO REPORT OF PATIENT INJURY RECEIVED. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND ALL REPORTS RECEIVED.

    Additional Manufacturer Narrative · 1

    MANUFACTURING RECORDS WERE REVIEWED, NO PRODUCT DEFICIENCY WAS IDENTIFIED, DOCUMENTATION SHOWS THAT THE PRODUCTION ORDER WAS MANUFACTURED ACCORDING TO SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    NO PRODUCT DEFICIENCY WAS IDENTIFIED, DOCUMENTATION SHOWS THAT THE PRODUCTION ORDER WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. POSSIBLE SIDE EFFECTS OF MULTIFOCAL LENS IMPLANT DO TO HALOS AND GLARE ARE KNOWN AND LABELED POSSIBLE SIDE EFFECT.

    Description of Event or Problem · 1

    THE NURSE REPORTED THE MULTIFOCAL INTRAOCULAR LENS WAS REMOVED AND REPLACED WITHOUT COMPLICATION DUE TO THE PATIENT'S DISPLEASURE WITH THE VISION, HALOS AND GLARE, SHE WAS EXPERIENCING. REPORTER STATED THERE WAS NOTHING PHYSICALLY WRONG WITH THE LENS. IN FOLLOW-UP WITH THE ACCOUNT, IT WAS LEARNED THE EXPLANTED LENS WAS REPLACED WITH A MONOFOCAL LENS OF THE SAME DIOPTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECNIS MULTIFOCAL MULTIFOCAL IOL MFK ABBOTT MEDICAL OPTICS ZMA00

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other