BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICOR LENS FRAGMENTATION SYSTEM

    MDR report key: 20014140 · Received August 21, 2024

    Report

    Report Number
    3012123033-2024-00005
    Event Type
    Injury
    Date Received
    August 21, 2024
    Date of Event
    July 18, 2024
    Report Date
    August 16, 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

    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 MICOR EXTRACTOR DEVICE HISTORY RECORDS WERE REVIEWED FOR THIS MANUFACTURING LOT AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS THAT RELATE TO THE REPORTED EVENT. THE SURGEON'S OPINION ON THE ETIOLOGY WAS POSSIBLY HOLDING THE MICOR EXTRACTOR TOO CLOSE TO THE TIP AND FAILURE TO RECOGNIZE THAT THE BSS WAS LOW (NO ALARM). THE SURGICAL VIDEO WAS PROVIDED TO THE MANUFACTURER FOR REVIEW AND THE FINDINGS WILL BE SUBMITTED IN A FOLLOW-UP REPORT. THE DEVICE LABELING IDENTIFIES CAPSULAR RUPTURE AS AN INHERENT SAFETY RISK. MANUFACTURER'S REFERENCE #: (B)(4).

    Description of Event or Problem · 0

    A PATIENT 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 MICOR EXTRACTOR NOSE CONE WAS NOT ATTACHED PROPERLY DURING THE NUCLEUS REMOVAL AND THERE WAS INSUFFICIENT IRRIGATION AND THE POSTERIOR CAPSULE RUPTURED. THE SURGEON STATED THAT THE ANTERIOR CHAMBER BOUNCE CAUGHT THE CAPSULE. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED BY THE SURGEON ON (B)(6) 2024. WHILE PERFORMING ASPIRATION OF THE NUCLEAR PIECES, THE MICOR EXTRACTOR NOSE CONE BECAME LOOSE AND SEPARATED FROM THE MICOR EXTRACTOR HANDPIECE. THERE WAS A LOSS OF INTRAOCULAR PRESSURE (IOP) IN THE ANTERIOR CHAMBER AND THE POSTERIOR CAPSULE TOUCHED THE MICOR TIP, FORMING A ROUND HOLE IN THE POSTERIOR CHAMBER WITH VITREOUS FLUID LOSS. VISCOELASTIC WAS INJECTED; HOWEVER, THERE WAS A SECOND LOSS OF IOP IN THE AC DUE TO INSUFFICIENT BALANCED SALT SOLUTION (BSS) AVAILABLE. AT THIS TIME THE POSTERIOR CAPSULAR TEAR EXTENDED AND THE NUCLEUS DROPPED INTO THE VITREOUS CAVITY. 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 3-PIECE INTRAOCULAR LENS MODEL WAS IMPLANTED IN THE SULCUS WITHOUT INCIDENT. ON (B)(6) 2024 THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH IRITIS IN THE RIGHT EYE. PREDNISOLONE TOPICAL EYE DROPS WERE PRESCRIBED FOR PRESUMED REBOUND IRITIS. THE PATIENT'S PROGNOSIS IS GOOD AND THERE HAS BEEN NO ADVERSE IMPACT ON VISION. AT THE LAST VISIT ON (B)(6) 2024 , THE PATIENT'S VISION IMPROVED FROM 20/800 PREOPERATIVELY TO 20/30.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1044186 MICOR LENS FRAGMENTATION SYSTEM PHACOFRAGMENTATION SYSTEM HQC CARL ZEISS MEDITEC CATARACT TECHNOLOGY INC. FG-50621 FG24042901 00860000122368

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention| S MILOOP