BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICOR LENS FRAGMENTATION SYSTEM

    MDR report key: 17329610 · Received July 14, 2023

    Report

    Report Number
    3012123033-2023-00003
    Event Type
    Injury
    Date Received
    July 14, 2023
    Date of Event
    June 14, 2023
    Report Date
    July 14, 2023
    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
    WI, 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, FUNCTIONAL TESTING, THEN DISASSEMBLED FOR INTERNAL INSPECTION. THERE WAS NO DAMAGE OR DEVICE MALFUNCTION IDENTIFIED AND THE DEVICE MET SPECIFICATIONS AND PERFORMED AS INTENDED. THE PUBLISHED LITERATURE WAS REVIEWED FOR COMPARISON OF THE FUNCTIONAL TEST RESULTS FOR FORCED OCCLUSION RESPONSE; THE INVESTIGATION DATA SHOWS THE DEVICE OPERATES WITHIN THE SAME EXPECTED RANGES FOR SIMILAR MARKETED PHACOEMULSIFICATION DEVICES. 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. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A POTENTIAL QUALITY ISSUE WITH RESPECT TO MANUFACTURING, DESIGN, OR LABELING. THE DEVICE LABELING IDENTIFIES CAPSULAR RUPTURE AS AN INHERENT SAFETY RISK. MANUFACTURER'S REFERENCE #:(B)(4).

    Description of Event or Problem · 0

    A 71-YEAR-OLD FEMALE PATIENT UNDERWENT CATARACT SURGERY IN THE LEFT EYE ON (B)(6) 2023 WHERE THE MICOR LENS FRAGMENTATION SYSTEM (EXTRACTOR AND DRIVE) WAS USED TO REMOVE THE CATARACTOUS LENS FRAGMENTS. DURING THE MICOR PROCEDURE THERE WAS ANTERIOR CHAMBER FLUCTUATION AND THE POSTERIOR CAPSULE TORE WHICH RESULTED IN VITREOUS FLUID LOSS. A VITRECTOMY WAS PERFORMED AND A 3-PIECE INTRAOCULAR LENS WAS IMPLANTED IN THE SULCUS. PREOPERATIVELY, THE PATIENT'S BEST CORRECTED VISUAL ACUITY (BCVA) WAS 20/25. POSTOPERATIVELY, THE PATIENT'S BCVA IMPROVED TO 20/20 AND THE PATIENT WAS REPORTED AS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180629 MICOR LENS FRAGMENTATION SYSTEM PHACOFRAGMENTATION SYSTEM HQC CARL ZEISS MEDITEC CATARACT TECHNOLOGY INC. FG-50621 FG23051801 00860000122368

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention