BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS CL

    MDR report key: 1832498 · Received September 13, 2010

    Report

    Report Number
    2648035-2010-00175
    Event Type
    Injury
    Date Received
    September 13, 2010
    Date of Event
    August 11, 2010
    Report Date
    August 17, 2010
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P880081/S032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE IOL WAS RECEIVED FOR ANALYSIS AND INSPECTED UNDER ILLUMINATED 10X MAGNIFICATION. THE EXPLANTED LENS WAS CUT IN 2 PIECES AND DISPLAYED ONE DISTORTED HAPTIC. WHILE WE WERE UNABLE TO DETERMINE THE SPECIFIC CAUSE OF THIS DAMAGE, OUR INVESTIGATION REASONABLY SUGGESTS, IT IS NOT MANUFACTURING RELATED. WE WILL CONTINUE TO MONITOR AND TREND ALL REPORTS RECEIVED.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THE INTRAOCULAR LENS (IOL) DECENTERED DUE TO HAPTIC DAMAGE THAT OCCURRED DURING THE IMPLANTATION. THE IOL WAS REMOVED AND REPLACED WITHOUT COMPLICATION 3 WEEKS AFTER THE INITIAL IMPLANT DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECNIS CL MONOFOCAL LENS HQL ABBOTT MEDICAL OPTICS Z9002

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention