BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS ITEC PRELOADED 1-PIECE IOL

    MDR report key: 2993637 · Received March 7, 2013

    Report

    Report Number
    2648035-2013-00116
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Report Date
    February 13, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THE INTRAOCULAR LENS REMAINS IMPLANTED. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HAPTICS STUCK TOGETHER AFTER INJECTION AND WERE HARD TO SEPARATE FROM EACH OTHER DURING THE IMPLANT OF THE INTRAOCULAR LENS. AFTER UNFOLDING OF THE LENS IN THE CAPSULAR BAG, THE HAPTICS STUCK ON THE OPTIC AND IT TOOK MORE THAN A MINUTE OR TWO (2) TO LOOSEN THE HAPTICS BY INSTRUMENT MANIPULATION EVEN THOUGH THERE WAS A SUFFICIENT AMOUNT OF HEALON. THERE WAS NO PATIENT INJURY OR COMPLICATION REPORTED. THERE WERE NO ISSUES WITH THE HANDLING OF THE INJECTOR AND THERE WAS A SUFFICIENT AMOUNT OF HEALON. THE IOL REMAINS IMPLANTED. THE DATE OF EVENT IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97248 TECNIS ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS PCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 Other