BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1-PIECE

    MDR report key: 2861583 · Received December 7, 2012

    Report

    Report Number
    2648035-2012-00375
    Event Type
    Injury
    Date Received
    December 7, 2012
    Date of Event
    October 31, 2012
    Report Date
    November 28, 2012
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS WAS RETURNED TO THE MANUFACTURER. THE SAMPLE WAS RECEIVED IN A PLASTIC BAG. THE SAMPLE WAS INSPECTED WITH A MICROSCOPE AT 10X MAGNIFICATION. VISUAL INSPECTION REVEALED SURFACE RESIDUALS (FIBERS, PARTICLES, AND STAINS) ON THE LENS SURFACE. SURFACE RESIDUALS ARE COMPATIBLE WITH HANDLING THE LENS OUT OF A STERILE ENVIRONMENT SUCH AS THE EXPLANT PROCESS. NO OTHER UNACCEPTABLE COSMETIC DEFECTS WERE FOUND IN THE RETURNED LENS. (B)(4): PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT REGARDING A PATIENT WHO HAD AN INTRAOCULAR LENS (IOL) REMOVED AND REPLACED WITH ANOTHER IOL AFTER THE ZONULES COLLAPSED. THE INCISION HAD TO BE ENLARGED FOR THE REMOVAL AND REQUIRED A SUTURE FOR CLOSURE. 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 66 YR Required Intervention