BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOW ENERGY ENDOCAPSULAR PHACO (LEEP) DEVICE

    MDR report key: 7130883 · Received December 19, 2017

    Report

    Report Number
    3012123033-2017-00004
    Event Type
    Injury
    Date Received
    December 19, 2017
    Date of Event
    August 7, 2017
    Report Date
    December 19, 2017
    Manufacturer
    IANTECH, INC.
    Product Code
    HNQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED BY THE USER AND IS NOT AVAILABLE FOR EVALUATION. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THIS MANUFACTURING LOT AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS THAT RELATE TO THE REPORTED EVENT. THE EVENT WAS ATTRIBUTED TO PATIENT MOVEMENT DURING THE PROCEDURE AND THERE WAS NO REPORT OF A DEVICE MALFUNCTION. CAPSULAR BAG DAMAGE AND VITREOUS LOSS IS AN INHERENT RISK OF CATARACT SURGERY. (B)(4).

    Description of Event or Problem · 1

    A PATIENT 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 NUCLEUS FRAGMENTATION, AFTER WHICH THE LEEP DEVICE WAS INTRODUCED INTO THE EYE. WHILE THE LEEP WAS IN THE EYE AND PRIOR TO MAKING THE FIRST RETRACTION, THE PATIENT RAISED HER HEAD UNEXPECTEDLY. THERE WERE NO OTHER DEVICE IN THE EYE AT THE TIME OF PATIENT MOVEMENT. THE LEEP WAS RETRACTED FROM THE EYE AND THE SURGEON PROCEEDED WITH LENS REMOVAL. WHEN THE FIRST QUADRANT WAS REMOVED IT WAS DISCOVERED THAT THE POSTERIOR CAPSULE HAD TORN AND VITREOUS FLUID WAS PRESENT. A VITRECTOMY WAS PERFORMED AND THE INTRAOCULAR LENS WAS IMPLANTED WITHOUT INCIDENT. POSTOPERATIVELY THE PATIENT IS STABLE AND THERE IS NO ADVERSE IMPACT ON THE PATIENT'S VISION AND NO SEQUELAE. THE SURGEON ATTRIBUTED THE CAPSULAR TEAR TO PATIENT MOVEMENT DURING CLOSURE OF THE LEEP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910431 LOW ENERGY ENDOCAPSULAR PHACO (LEEP) DEVICE OPHTHALMIC HOOK HNQ IANTECH, INC. FG-11881 FG20170605-01

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention