BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS CL

    MDR report key: 1840554 · Received September 21, 2010

    Report

    Report Number
    2648035-2010-00182
    Event Type
    Injury
    Date Received
    September 21, 2010
    Date of Event
    August 23, 2010
    Report Date
    August 23, 2010
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P880081/S032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INJURY OCCURRED, PATIENT HAD A WEAK CAPSULAR BAG AND A FLOPPY IRIS PRECLUDING IMPLANTATION OF THIS INTRAOCULAR LENS. (B)(4). THE IOL WAS NOT RECEIVED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED FROM THE DOCTOR REGARDING THE PATIENT'S EYE ANATOMY WE HAVE NO REASON TO SUSPECT THE LENS CAUSED OR CONTRIBUTED TO THIS EVENT. WE WILL CONTINUE TO MONITOR AND TREND ALL REPORTS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE INTRAOCULAR LENS WAS REMOVED DURING THE INITIAL SURGERY DUE TO THE PATIENT WEAK ANTERIOR CHAMBER SUPPORT AND A FLOPPY IRIS. THE INCISION WAS ENLARGED TO REMOVE THE LENS, NO PATIENT INJURY OCCURRED.

    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 Required Intervention