BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MILOOP

    MDR report key: 19857723 · Received July 29, 2024

    Report

    Report Number
    9615010-2024-00006
    Event Type
    Injury
    Date Received
    July 29, 2024
    Date of Event
    July 1, 2024
    Report Date
    July 29, 2024
    Manufacturer
    CARL ZEISS MEDITEC AG (OBERKOCHEN)
    Product Code
    HNQ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAD BEEN DISCARDED BY THE USER. THEREFORE, A PROPER DEVICE EVALUATION IS NOT POSSIBLE. THE SURGEON BELIEVES THE PATIENT'S OCULAR HISTORY (SAME EVENT IN FELLOW EYE) LIKELY CAUSED OR CONTRIBUTED TO THE EVENT, BUT THERE WERE EARLY COMMENTS FROM THE SURGEON POTENTIALLY IMPLICATING THE MILOOP AND/OR THE MICOR AS CONTRIBUTING FACTORS. THE DEVICE LABELING IDENTIFIES CAPSULAR RUPTURE AS AN INHERENT SAFETY RISK.

    Description of Event or Problem · 0

    A PATIENT WITH A DENSE CATARACT AND WEAK ZONULES UNDERWENT CATARACT SURGERY IN THE RIGHT EYE ON (B)(6) 2024 WHERE THE MILOOP AND MICOR LENS FRAGMENTATION SYSTEM WERE USED TO FRAGMENT AND REMOVE THE CATARACTOUS LENS FRAGMENTS. THE MILOOP WAS USED TO SECTION THE LENS INTO 4 QUADRANTS. THE MICOR EXTRACTOR WAS THEN USED TO REMOVE 2 QUADRANTS, AFTER WHICH TIME THE PRESENCE OF ZONULAR DIALYSIS BECAME EVIDENT. THE REMAINING 2 QUARTERS OF THE CATARACTOUS LENS DESCENDED POSTERIORLY THROUGH A POSTERIOR CAPSULAR TEAR AND INTO THE VITREOUS CAVITY. THE EXACT TIMING OF THE ZONULAR/CAPSULAR TEAR IS NOT KNOWN, BUT THE SURGEON STATED THE DAMAGE OCCURRED DURING LENS FRAGMENTATION AND REPORTED A POST-OCCLUSION SURGE DURING MICOR. PATIENT FOLLOW-UP INFORMATION WAS REQUESTED FROM THE SURGEON. ADDITIONAL FOLLOW-UP WAS PROVIDED BY THE SURGEON ON (B)(6) 2024, WHO REPORTS THE PATIENT WAS DOING WELL AND THERE HAS BEEN NO SEQUELAE AND NO ADVERSE IMPACT ON VISION. A RETINA SPECIALIST WAS AVAILABLE AND INTERVENED DURING THE INITIAL SURGERY, A PARS PLANA VITRECTOMY WAS PERFORMED AND THE FALLEN LENS FRAGMENTS WERE REMOVED FROM THE VITREOUS. A DIFFERENT 3-PIECE INTRAOCULAR LENS MODEL WAS IMPLANTED. AT THE PATIENT'S LAST VISIT ON (B)(6) 2024, BCVA IMPROVED TO 20/50 (COMPARED TO 20/200 PREOPERATIVELY). THE PATIENT HAD A RELEVANT HISTORY OF ZONULAR WEAKNESS AND A DROPPED NUCLEUS DURING CATARACT SURGERY IN THE FELLOW EYE. THE PATIENT HAS HAD MULTIPLE RETINAL PROCEDURES IN BOTH EYES BY THE SAME RETINA SPECIALIST WHO COMPLETED THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280771 MILOOP MILOOP HNQ CARL ZEISS MEDITEC AG (OBERKOCHEN) NOT AVAILABLE NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention| S MICOR LENS FRAGMENTATION SYSTEM