BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICOR LENS FRAGMENTATION SYSTEM

    MDR report key: 20164637 · Received September 6, 2024

    Report

    Report Number
    3012123033-2024-00007
    Event Type
    Injury
    Date Received
    September 6, 2024
    Date of Event
    July 13, 2023
    Report Date
    September 6, 2024
    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
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MICOR EXTRACTOR WAS DISCARDED BY THE CUSTOMER AT THE TIME OF THE EVENT AND IS NOT AVAILABLE FOR EVALUATION. NO DEVICE IDENTIFIERS ARE AVAILABLE. THE SURGEON PROVIDED THEIR MEDICAL OPINION IN SECTION B5 DESCRIBING THE FACTORS THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. WHILE THE DEVICE WAS NOT AVAILABLE FOR TESTING, BASED ON REVIEW OF THE DEVICE DESIGN HISTORY FILE, THE MICOR SYSTEM WAS DESIGNED TO BUILD VACUUM TO MAXIMUM POTENTIAL IN THE SAME TIMEFRAME AS PHACOEMULSIFICATION. HOWEVER, THE MICOR DOES NOT HAVE A COMPUTER DISPLAY AND WAS NOT DESIGNED WITH INDICATORS FOR METRICS SUCH VACUUM LEVEL, FLUIDICS, ETC. IMPORTANTLY, THE USER HAS THE ABILITY TO BREAK VACUUM AT ANY TIME DURING LENS EXTRACTION TO MITIGATE THE RISK OF CAPSULAR BAG DAMAGE. THE DEVICE LABELING IDENTIFIES CAPSULAR RUPTURE AS AN INHERENT SAFETY RISK. MANUFACTURER'S REFERENCE (B)(4).

    Description of Event or Problem · 0

    A PATIENT UNDERWENT CATARACT SURGERY IN THE RIGHT EYE ON (B)(6) 2023 WHERE THE MICOR LENS FRAGMENTATION SYSTEM WAS USED TO REMOVE THE CATARACTOUS LENS FRAGMENTS. THE MANUFACTURER BECAME AWARE OF THE EVENT APPROXIMATELY 13 MONTHS AFTERWARDS AND ADDITIONAL INFORMATION WAS REQUESTED FROM THE SURGEON WHO PROVIDED A DETAILED ACCOUNT OF THE EVENT (BASED ON SURGICAL VIDEO). THE SURGEON NOTICED SMALL HOLE IN THE POSTERIOR CAPSULE AT END OF IRRIGATION AND ASPIRATION CORTEX REMOVAL. SURGICAL TECHNIQUE WAS EMPLOYED APPROPRIATELY, I.E., NOT ALLOWING CAPSULAR BAG TO BOW FORWARD; HOWEVER, A SMALL AMOUNT OF VITREOUS CAME THROUGH THE HOLE AND WAS REMOVED WITH A VITRECTOR (ANTERIOR VITRECTOMY PERFORMED). THE SURGEON ATTRIBUTED THE EVENT TO THE MICOR DEVICE CITING "SNAPPINESS" WHICH IS FURTHER CLARIFIED BELOW. "THERE WAS A THIN EPINUCLEAR PLATE [OF THE CATARACT] PRESENT. IN BOTH PHACO[EMULSIFICATION] AND MICOR, WHEN YOU REACH FOR A THIN REMAINING PIECE, THERE IS A RISK OF THE DEVICE BUILDING VACUUM AND POPPING THROUGH THE REMAINING [CATARACT] PIECE AND THEN INTERACTING WITH THE POSTERIOR CAPSULE, THEREBY CAUSING A TEAR. THERE WAS A CLINICAL DECISION MADE TO REACH FOR THE REMAINING THIN PIECE THAT CONTRIBUTED TO THE ADVERSE EVENT. WHILE I ATTRIBUTE THE QUICK BUILD IN VACUUM TO THE DEVICE, THE ADVERSE EVENT WAS ALSO ATTRIBUTABLE TO SURGEON CLINICAL DECISION MAKING. ON THE OTHER HAND, I CAN SAY WITH ABSOLUTE CONFIDENCE THAT IF A SIMILAR SITUATION HAD OCCURRED WITH PHACO (PC TEAR FROM REACHING FOR AN EPINUCLEAR PIECE), THAT THE SEQUELAE WOULD HAVE BEEN VERY DIFFERENT, AND WORSE. WHENEVER THE PHACO NEEDLE CREATES A PC [POSTERIOR CAPSULE] TEAR, THE HOLE HAS JAGGED EDGES AND SO IT IMMEDIATELY EXPANDS UNDER THE HIGH FLOW STATE. WITH MICOR, THE HOLE SEEMS TO NEVER EXPAND BECAUSE OF THE VERY SMOOTH EDGES AND THE LOW FLOW OF IRRIGATION. HAD I BEEN USING PHACO, THE PATIENT WOULD HAVE ENDED UP WITH A 3-PIECE MONOFOCAL IOL [INTRAOCULAR LENS] IN THE SULCUS, DESPITE HAVING PAID FOR A PREMIUM IOL. BECAUSE OF THE NATURE OF THE PC TEAR, I WAS STILL ABLE TO PLACE A SINGLE PIECE MULTIFOCAL TORIC IOL IN THE BAG. I'VE NEVER BEEN ABLE TO SAVE A SIMILAR SITUATION TO THIS WITH PHACO LIKE I DID. MY PRESUMPTION IS THAT IT WAS THE MICOR'S OTHER FEATURES (LOW FLOW AND SMOOTH TIP EDGES) THAT MADE A VERY GOOD SITUATION OUT OF AN ADVERSE EVENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1066650 MICOR LENS FRAGMENTATION SYSTEM PHACOFRAGMENTATION SYSTEM HQC CARL ZEISS MEDITEC CATARACT TECHNOLOGY INC. FG-50621 00860000122368

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Unknown Disability| R