BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICOR LENS FRAGMENTATION SYSTEM

    MDR report key: 11668580 · Received April 14, 2021

    Report

    Report Number
    3012123033-2021-00003
    Event Type
    Injury
    Date Received
    April 14, 2021
    Date of Event
    March 17, 2021
    Report Date
    April 14, 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 RETURNED TO THE MANUFACTURER FOR AND SUBJECTED TO MICROSCOPIC VISUAL INSPECTION, DIMENSIONAL INSPECTION, AND FUNCTIONAL TESTING. THERE WAS NO EVIDENCE OF A DEVICE MALFUNCTION. THE DEVICE MET SPECIFICATIONS AND FUNCTIONED AS INTENDED. THE 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 THOUGHT THERE MAY HAVE BEEN PREEXISTING ZONULAR AND/OR VITREOUS ADHESION ISSUES THAT MAY HAVE PREDISPOSED THE EVENT, POTENTIALLY CAUSING THE CAPSULAR BAG TO TEAR WHEN THE LENS WAS ROTATED OR WHEN LENS FRAGMENTS WERE REMOVED FROM THE BAG. SINCE THE MICOR DEVICE WAS IN USE WHEN THE INJURY WAS IDENTIFIED, USE ERROR WITH THE EXTRACTOR CANNOT BE RULED OUT AS A POTENTIAL CONTRIBUTING FACTOR. 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 FOLLOWING RISKS ARE IDENTIFIED IN THE DEVICE LABELING: AS WITH ANY ENDOCAPSULAR LENS FRAGMENTATION TECHNIQUE, THERE ARE RISKS ASSOCIATED WITH ENDOTHELIAL CELL LOSS, CAPSULAR RUPTURE, RISK OF INFECTION, ADVERSE REACTION TO MATERIALS, MECHANICAL FAILURE OR BREAKAGE OF THE DEVICE, AND TISSUE/VASCULAR TRAUMA OR PERFORATION. MANUFACTURER'S REFERENCE #: (B)(4).

    Description of Event or Problem · 1

    A (B)(6) YEAR-OLD FEMALE 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. A POSTERIOR CAPSULE TEAR WAS OBSERVED INTRAOPERATIVELY. THE EVENT REQUIRED AN ANTERIOR VITRECTOMY AND A CHANGE IN THE SURGICAL PLAN TO A IMPLANT A 3-PIECE SULCUS-FIXATED INTRAOCULAR LENS (IOL) INSTEAD OF A STANDARD SINGLE-PIECE IOL. THE SURGEON NOTICED VITREOUS AND VERY WEAK ZONULES APPROXIMATELY 3.5 CLOCK HOURS FROM WHERE HE WAS WORKING WITH THE MICOR EXTRACTOR. THE EVENT HAD NO ADVERSE IMPACT ON THE PATIENT'S VISION AND THERE WAS NO SEQUELAE. ONE DAY POSTOPERATIVELY THE PATIENT'S BEST CORRECTED VISUAL ACUITY WAS 20/40.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560697 MICOR LENS FRAGMENTATION SYSTEM PHACOFRAGMENTATION UNIT HQC CARL ZEISS MEDITEC CATARACT TECHNOLOGY, INC. FG-50621 FG21020101 00860000122368

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention