BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS 1-PIECE

    MDR report key: 2152310 · Received July 7, 2011

    Report

    Report Number
    2648035-2011-00130
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Report Date
    June 9, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P98040/S015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LENS MET ALL SPECIFICATIONS PRIOR TO RELEASE. ALL CURRENTLY AVAILABLE INFORMATION IS INCLUDED IN THIS REPORT. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY SHOULD ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE LENS REMAINS IMPLANTED IN PATIENT.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED THAT AFTER IMPLANTATION OF A TECNIS 1-PIECE INTRAOCULAR LENS, THE HAPTICS STUCK TO THE OPTIC LONGER THAN NORMAL, APPROXIMATELY 1.5 - 2 MINUTES UNTIL THEY UNFOLDED . THE LENS REMAINS IMPLANTED. NO PATIENT INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1