BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICOR LENS FRAGMENTATION SYSTEM

    MDR report key: 11711305 · Received April 22, 2021

    Report

    Report Number
    3012123033-2021-00005
    Event Type
    Injury
    Date Received
    April 22, 2021
    Date of Event
    March 23, 2021
    Report Date
    April 22, 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. A VIDEO RECORDING OF THE SURGERY WAS PROVIDED TO THE MANUFACTURER AND REVIEWED. THE ANALYSIS RESULTED IN A CONCLUSION IS THAT THE EVENT WAS CAUSED BY USE ERROR AND A DEVICE MALFUNCTION WAS HIGHLY UNLIKELY. 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) PATIENT UNDERWENT CATARACT SURGERY IN THE LEFT EYE ON (B)(6) 2021 WHERE THE MICOR LENS FRAGMENTATION SYSTEM (EXTRACTOR AND DRIVE) WAS USED TO FRAGMENT AND REMOVE THE CATARACTOUS LENS. THE SURGEON REPORTED AN INTRAOPERATIVE POSTERIOR CAPSULAR BAG TEAR. THE TEAR WAS OBSERVED WHILE USING THE MICOR DEVICE WHEN THE SURGEON INADVERTENTLY CAUGHT THE POSTERIOR CAPSULE WITH THE MICOR BAG POLISHING TIP AND CAUSED A VERY SMALL TEAR IN THE POSTERIOR CAPSULE. THERE WAS NO LOSS OF VITREOUS FLUID. ADDITIONAL INFORMATION WAS REQUESTED AND THE SURGEON ATTRIBUTED THE TEAR TO USE ERROR, STATING "PILOT ERROR" AND "CAUGHT CAPSULE WITH [THE BAG POLISHING TIP]." THE SURGEON ALSO REPORTED THAT THE DEVICE FELT "SNAPPY AND THE ASPIRATION WAS AGGRESSIVE". THE COMPROMISED CAPSULAR BAG REQUIRED A CHANGE IN THE ORIGINAL SURGICAL PLAN; SPECIFICALLY, A DIFFERENT IOL WAS USED WITH PLACEMENT IN THE CILIARY SULCUS (NOT SUTURED) INSTEAD OF PLANNED IOL IMPLANTATION IN THE CAPSULAR BAG. POSTOPERATIVELY, THE PATIENT IS DOING WELL AND THERE WAS NO ADVERSE IMPACT ON VISION, NO VITREOUS LOSS, AND NO VITRECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603788 MICOR LENS FRAGMENTATION SYSTEM PHACOFRAGMENTATION UNIT HQC CARL ZEISS MEDITEC CATARACT TECHNOLOGY, INC. FG-50621 FG21020101 00860000122368

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention