BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICOR LENS FRAGMENTATION SYSTEM

    MDR report key: 11742979 · Received April 28, 2021

    Report

    Report Number
    3012123033-2021-00006
    Event Type
    Injury
    Date Received
    April 28, 2021
    Date of Event
    March 30, 2021
    Report Date
    April 28, 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
    NV, 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. THERE WAS NO REPORT OF A DEVICE MALFUNCTION AND THE EVENT WAS ATTRIBUTED TO UNEXPECTED PATIENT MOVEMENT. 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 MALE 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 SYSTEM WAS FUNCTIONING NORMALLY WITH APPROXIMATELY HALF OF THE CATARACTOUS LENS REMOVED WHEN THE PATIENT COUGHED UNEXPECTEDLY WITH ENOUGH FORCE TO RAISE HIS HEAD FROM THE OPERATING TABLE. THE MICOR AND OTHER INSTRUMENTS WERE REMOVED FROM THE EYE AS QUICKLY AS POSSIBLE. THE SURGEON SUBSEQUENTLY REENTERED THE EYE AND RESUMED LENS EXTRACTION; HOWEVER, AFTER APPROXIMATELY 10-20 SECONDS AND THE REMOVAL OF ADDITIONAL LENS FRAGMENTS, A POSTERIOR CAPSULAR TEAR WAS VISIBLE. AT THIS POINT, LENS EXTRACTION WITH THE MICOR WAS DISCONTINUED AND THE CAPSULAR TEAR WAS ADDRESSED. ADDITIONAL INFORMATION WAS REQUESTED AND IT WAS CLARIFIED THAT THE PATIENT MOVEMENT OCCURRED WHILE THE INSTRUMENTS WERE INSIDE THE EYE; THE TEAR WAS BELIEVED TO BE LIMITED TO THE ANTERIOR CAPSULE UNTIL THE CASE PROCEEDED AND THE TEAR EXTENDED POSTERIORLY WITH VITREOUS LOSS. A VITRECTOMY WAS PERFORMED AND THE CAPSULE DAMAGE REQUIRED A CHANGE IN THE ORIGINAL SURGICAL PLAN; SPECIFICALLY, A DIFFERENT INTRAOCULAR LENS (IOL) WAS USED WITH PLACEMENT IN THE ANTERIOR CHAMBER INSTEAD OF PLANNED POSTERIOR CHAMBER IOL IMPLANTATION IN THE CAPSULAR BAG. POSTOPERATIVELY, THE PATIENT IS DOING WELL AND THERE HAS BEEN NO ADVERSE IMPACT ON VISION AND NO SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632580 MICOR LENS FRAGMENTATION SYSTEM PHACOFRAGMENTATION UNIT HQC CARL ZEISS MEDITEC CATARACT TECHNOLOGY, INC. FG-50621 FG21020401 00860000122368

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention