BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOW ENERGY ENDOCAPSULAR PHACO (LEEP) DEVICE

    MDR report key: 7062194 · Received November 27, 2017

    Report

    Report Number
    3012123033-2017-00001
    Event Type
    Injury
    Date Received
    November 27, 2017
    Date of Event
    September 11, 2017
    Report Date
    November 27, 2017
    Manufacturer
    IANTECH, INC.
    Product Code
    HNQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED BY THE USER AND IS NOT AVAILABLE FOR EVALUATION. THE EVENT WAS SOLELY ATTRIBUTED TO USE ERROR AND THERE WAS NO DEVICE MALFUNCTION. CAPSULAR BAG DAMAGE IS AN INHERENT RISK OF CATARACT SURGERY. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THIS LOT NUMBER AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS THAT RELATE TO THE REPORTED EVENT. MANUFACTURER'S REFERENCE #: (B)(4).

    Description of Event or Problem · 1

    A PATIENT WITH A MODERATELY ADVANCED SENILE CATARACT UNDERWENT CATARACT SURGERY IN THE RIGHT EYE ON (B)(6) 2017 WHERE THE LEEP DEVICE WAS USED TO SECTION THE CATARACTOUS LENS INTO FRAGMENTS. DURING SURGERY, A FEMTOSECOND LASER WAS USED FOR THE CAPSULOTOMY AND NUCLEUS FRAGMENTATION, AFTER WHICH THE LEEP DEVICE WAS INTRODUCED INTO THE EYE AND NUCLEUS ENGAGEMENT WAS INITIATED. DURING THIS PORTION OF THE PROCEDURE THERE WAS AGGRESSIVE MANIPULATION WITH OVER-ROTATION AND EXTENSION PAST THE MIDLINE AS WELL AS MULTIPLE SWEEPS DURING CAPSULE POLISHING. AT SOME POINT DURING THE PHACOEMULSIFICATION PROCEDURE AND PHACO TIP CHOPPING IT WAS OBSERVED THAT THE POSTERIOR CAPSULE HAD RUPTURED. THE EVENT REQUIRED SECONDARY SURGICAL INTERVENTION TO PERFORM AN ANTERIOR VITRECTOMY AND REMOVE THE LENS FRAGMENTS FROM THE ANTERIOR CHAMBER. A THREE-PIECE INTRAOCULAR LENS WAS IMPLANTED WITHOUT INCIDENT. THERE WAS NO ADVERSE IMPACT ON THE PATIENT'S VISION AND NO SEQUELAE. THE SURGEON WAS UNABLE TO ATTRIBUTE THE CAPSULAR DAMAGE TO ONE SPECIFIC DEVICE AND STATED THAT USE OF ANY OF THE CONCURRENT DEVICES (FEMTOSECOND LASER, PHACOEMULSIFICATION EQUIPMENT, OR THE LEEP) MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840845 LOW ENERGY ENDOCAPSULAR PHACO (LEEP) DEVICE OPHTHALMIC HOOK HNQ IANTECH, INC. FG-11881 FG20170828-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention