BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1-PIECE

    MDR report key: 2925637 · Received January 22, 2013

    Report

    Report Number
    2648035-2013-00035
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 7, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRIOR TO RELEASE TO MARKET, THE INTRAOCULAR LENS MET ALL MANUFACTURING SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT REQUIRED REMOVAL OF THE INTRAOCULAR LENS (IOL) DURING THE SAME SURGERY DUE TO A CAPSULAR TEAR. AN INCISION ENLARGEMENT WAS REQUIRED TO REMOVE THE LENS. REPORTEDLY, THE CAPSULAR TEAR OCCURRED DURING THE PHACO PROCEDURE WITH THE (ALCON) INFINITY PHACO MACHINE. THE PATIENT WAS DOING WELL AND THE PROCEDURE WAS COMPETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29661 TECNIS 1-PIECE MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention