BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICOR LENS FRAGMENTATION SYSTEM

    MDR report key: 12844895 · Received November 19, 2021

    Report

    Report Number
    3012123033-2021-00015
    Event Type
    Injury
    Date Received
    November 19, 2021
    Date of Event
    October 21, 2021
    Report Date
    November 19, 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
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 MILOOP DEVICE USED DURING THE PROCEDURE IS NOT SUSPECTED AS CAUSING OR CONTRIBUTING TO THE EVENT. SURGICAL VIDEO WAS PROVIDED TO THE MANUFACTURER FOR REVIEW. VIDEO FOOTAGE REVIEWED BY COMPANY PERSONNEL (MEDICAL AND ENGINEERING) DID NOT REVEAL ANY EVIDENCE OF A DEVICE MALFUNCTION. THE DEVICE LABELING IDENTIFIES CAPSULAR RUPTURE AS A SAFETY RISK. THIS MDR IS FOR THE MICOR EXTRACTOR. REFER TO MDR # 3012123033-2021-00016 FOR THE SECOND DEVICE INVOLVED IN THIS EVENT. MANUFACTURER'S REFERENCE #: (B)(4).

    Description of Event or Problem · 0

    A (B)(6)-OLD PATIENT UNDERWENT CATARACT SURGERY IN THE LEFT EYE ON (B)(6) 2021 WHERE THE MILOOP AND MICOR LENS FRAGMENTATION SYSTEM (EXTRACTOR AND DRIVE) WERE USED TO FRAGMENT AND REMOVE THE CATARACTOUS LENS. THE PATIENT'S POSTERIOR CAPSULE TORE DURING SURGERY. THERE WAS NO LOSS OF VITREOUS FLUID, NO VITRECTOMY, AND NO CHANGE TO THE INTRAOCULAR LENS IMPLANTED. THE SURGEON REPORTED THE MICOR "FELT RUNNING AT TOO HIGH THROTTLE" AND HE "GOT TOO CLOSE TO THE [CAPSULAR] BAG". THE SURGICAL VIDEO REVEALED THE FOLLOWING ADDITIONAL INFORMATION AND INSIGHT. IT SHOULD BE NOTED THAT THE VIDEO RESOLUTION WAS LOW AND IT WAS NOT POSSIBLE TO IDENTIFY EXACTLY WHEN THE CAPSULAR TEAR OCCURRED. THE PATIENT HAD A DARK IRIS AND A SMALL PUPIL WHICH REQUIRED USE OF AN IRIS RETRACTOR AT THE BEGINNING OF SURGERY. THE MILOOP WAS USED TO BISECT THE PATIENT'S GRADE 3 CATARACTOUS LENS. THERE WERE NO PROBLEMS WITH THE TECHNIQUE USED TO EXECUTE THE MILOOP PROCEDURE. THERE WAS NO EVIDENCE OF A DEVICE MALFUNCTION WITH THE MILOOP OR MICOR DEVICES AND THERE WAS NO EVIDENCE OF AN OVERSPEED CONDITION. BASED ON THE VIDEO EVIDENCE, IT IS POSSIBLE THAT THE IRIS RETRACTOR AND SURGICAL TECHNIQUE DURING ITS REMOVAL AND/OR BAG POLISHING TECHNIQUE WITH ANOTHER DEVICE MAY HAVE CAUSED THE TEAR. PATIENT FOLLOW-UP HAS BEEN REQUESTED FROM THE SURGEON ON SEVERAL OCCASIONS, BUT NO RESPONSE HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1744863 MICOR LENS FRAGMENTATION SYSTEM PHACOFRAGMENTATION UNIT HQC CARL ZEISS MEDITEC CATARACT TECHNOLOGY, INC. FG-50621 FG21050401 00860000122368

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Unknown Required Intervention IRIS RETRACTOR| MICOR DRIVE| MILOOP| SINSKY HOOK