BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1-PIECE

    MDR report key: 1810561 · Received August 22, 2010

    Report

    Report Number
    2648035-2010-00152
    Event Type
    Injury
    Date Received
    August 22, 2010
    Date of Event
    April 23, 2010
    Report Date
    July 31, 2010
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P98040/S015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED AND INSPECTED UNDER ILLUMINATED 10X MAGNIFICATION. RESULTS SHOWED 2 BROKEN HAPTICS AND AN OPTIC CUT IN HALF. INFORMATION RECEIVED FROM THE ACCOUNT INDICATED, THE IOL WAS DAMAGED DURING IMPLANTATION BY AN UNIDENTIFIED INSERTION SYSTEM. PRIOR TO RELEASE THE LENS MET ALL MANUFACTURING SPECIFICATIONS. WHILE WE WERE UNABLE TO DETERMINE THE CAUSE OF THIS EVENT OUR INVESTIGATION REASONABLY SUGGESTS IT IS NOT MANUFACTURING RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ACCOUNT THAT DURING ROUTINE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT THE TRAILING HAPTIC BROKE. THE INCISION WAS ENLARGED TO REMOVE THE INITIAL IMPLANT AND A SECOND IOL IMPLANTED WITHOUT COMPLICATION. REPORTER STATED THERE WAS NO PATIENT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other