BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICOR LENS FRAGMENTATION SYSTEM

    MDR report key: 19822648 · Received July 24, 2024

    Report

    Report Number
    3012123033-2024-00004
    Event Type
    Injury
    Date Received
    July 24, 2024
    Date of Event
    July 1, 2024
    Report Date
    July 24, 2024
    Manufacturer
    CARL ZEISS MEDITEC CATARACT TECHNOLOGY INC.
    Product Code
    HQC
    UDI-DI
    00860000122368
    PMA / PMN Number
    K222236
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE IDENTIFIERS WERE AVAILABLE; HOWEVER, THE MICOR EXTRACTOR WAS RETURNED TO THE MANUFACTURER AND EVALUATED. THE DEVICE WAS SUBJECTED TO VISUAL INSPECTION AND FUNCTIONAL TESTING, WHICH CONSISTED OF FLOW, VACUUM, SURGE, AND CUTTER TESTING. THERE WAS NO DAMAGE OR DEVICE MALFUNCTION IDENTIFIED AND THE DEVICE MET SPECIFICATIONS AND PERFORMED AS INTENDED. THE SURGE TESTING WITH AN ARTIFICIAL EYE REVEALED THE PRESSURE DROP WAS WITHIN SPECIFICATION. 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. MANUFACTURER'S REFERENCE #: (B)(4).

    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 JULY 18, 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 JULY 9, 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
    2343629 MICOR LENS FRAGMENTATION SYSTEM PHACOFRAGMENTATION SYSTEM HQC CARL ZEISS MEDITEC CATARACT TECHNOLOGY INC. FG-50621 00860000122368

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Disability| R MILOOP