BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICOR LENS FRAGMENTATION SYSTEM

    MDR report key: 12035040 · Received June 21, 2021

    Report

    Report Number
    3012123033-2021-00007
    Event Type
    Injury
    Date Received
    June 21, 2021
    Date of Event
    May 25, 2021
    Report Date
    June 21, 2021
    Manufacturer
    CARL ZEISS MEDITEC CATARACT TECHNOLOGY, INC.
    Product Code
    HQC
    UDI-DI
    00860000122368
    PMA / PMN Number
    K200584
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MICOR EXTRACTOR WAS DISCARDED BY THE USER FACILITY AND IS NOT AVAILABLE FOR EVALUATION. THE 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 A SAFETY RISK. MANUFACTURER'S REFERENCE #: (B)(4).

    Description of Event or Problem · 1

    A (B)(6) PATIENT UNDERWENT CATARACT SURGERY IN THE RIGHT EYE ON (B)(6) 2021 WHERE THE MICOR LENS FRAGMENTATION SYSTEM (EXTRACTOR AND DRIVE) WAS USED TO FRAGMENT AND REMOVE THE CATARACTOUS LENS. THE PATIENT'S POSTERIOR CAPSULE TORE DURING SURGERY. THE TEAR, DESCRIBED AS SMALL, WAS DETECTED WHILE USING THE MICOR DEVICE AND DURING CAPSULAR BAG POLISHING (AFTER THE SURGEON HAD IMPLANTED THE INTRAOCULAR LENS). ACCORDING TO THE COMPANY REPRESENTATIVE, IT APPEARED AS THOUGH THE SURGEON INADVERTENTLY CAPTURED A PORTION OF THE CAPSULE DURING IRRIGATION/ASPIRATION, WHICH RESULTED IN A POSTERIOR CAPSULAR BAG TEAR. THERE WAS NO VITREOUS PRESENT IN THE ANTERIOR CHAMBER AND THE SURGEON REPORTS NO ADVERSE IMPACT ON VISION OR SEQUELAE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    928587 MICOR LENS FRAGMENTATION SYSTEM PHACOFRAGMENTATION UNIT HQC CARL ZEISS MEDITEC CATARACT TECHNOLOGY, INC. FG-50621 FG21031001 00860000122368

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention