BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1-PIECE

    MDR report key: 2801232 · Received October 23, 2012

    Report

    Report Number
    2648035-2012-00327
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    June 4, 2012
    Report Date
    October 9, 2012
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - EXPLANT OF INTRAOCULAR LENS; 3191 USED FOR INCISION ENLARGED; SUTURES REQUIRED. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT FROM A SURGERY CENTER THAT AN INTRAOCULAR LENS (IOL) WAS MIS-LOADED DUE TO A HANDLING/USER ERROR BUT THE LENS WAS IMPLANTED ANYWAY. EVIDENTALLY SOMETHING WAS NOT RIGHT AND THE LENS WAS EXPLANTED. THE INCISION HAD TO BE ENLARGED, ANOTHER LENS WAS IMPLANTED DURING THE SAME PROCEDURE; SUTURES WERE USED TO CLOSE THE INCISION. THE REPORT STATES THAT THE LENS ITSELF WAS EITHER DESTROYED/DISCARDED OR LOST. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECNIS 1-PIECE MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention