BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICOR LENS FRAGMENTATION SYSTEM

    MDR report key: 23343408 · Received October 20, 2025

    Report

    Report Number
    3012123033-2025-00004
    Event Type
    Injury
    Date Received
    October 20, 2025
    Date of Event
    September 25, 2025
    Report Date
    October 20, 2025
    Manufacturer
    CARL ZEISS MEDITEC CATARACT TECHNOLOGY INC.
    Product Code
    HQC
    UDI-DI
    00860000122368
    PMA / PMN Number
    K242801
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 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 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 LEFT EYE WHERE THE MICOR LENS FRAGMENTATION SYSTEM WAS USED TO REMOVE THE CATARACTOUS LENS FRAGMENTS. A POSTERIOR CAPSULAR TEAR OCCURRED DURING SURGERY AND A PORTION OF THE LENS NUCLEUS FELL POSTERIORLY INTO THE VITREOUS CAVITY. THE NUCLEUS REMNANT WAS LEFT BEHIND FOR THE RETINA SPECIALIST TO ADDRESS AND A 3-PIECE INTRAOCULAR LENS WAS IMPLANTED IN THE SULCUS. THE SURGEON WAS UNSURE WHEN THE CAPSULE RUPTURE OCCURRED. PATIENT FOLLOW-UP INFORMATION WAS REQUESTED FROM THE PHYSICIAN'S OFFICE ON THREE SEPARATE OCCASIONS, BUT NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783252 MICOR LENS FRAGMENTATION SYSTEM PHACOFRAGMENTATION SYSTEM HQC CARL ZEISS MEDITEC CATARACT TECHNOLOGY INC. FG-50621 FG24070210 00860000122368

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Unknown Required Intervention