BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MILOOP LENS FRAGMENTATION DEVICE

    MDR report key: 12558840 · Received September 30, 2021

    Report

    Report Number
    3012123033-2021-00013
    Event Type
    Injury
    Date Received
    September 30, 2021
    Date of Event
    September 3, 2021
    Report Date
    September 30, 2021
    Manufacturer
    CARL ZEISS MEDITEC CATARACT TECHNOLOGY, INC.
    Product Code
    HQC
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE MILOOP DEVICE WAS DISCARDED BY THE USER FACILITY AND WAS NOT AVAILABLE FOR EVALUATION. DEVICE IDENTIFIERS HAVE BEEN REQUESTED. THE CAUSE OF THE POSTERIOR CAPSULAR TEAR WAS NOT DETERMINED BY THE PHYSICIAN. THE DEVICE LABELING IDENTIFIES CAPSULAR RUPTURE AS A SAFETY RISK. MANUFACTURER'S REFERENCE #: (B)(4).

    Description of Event or Problem · 0

    AN (B)(6)-OLD FEMALE PATIENT UNDERWENT CATARACT SURGERY IN THE RIGHT EYE ON (B)(6) 2021 WHERE THE MILOOP LENS FRAGMENTATION DEVICE WAS USED TO FRAGMENT THE CATARACTOUS LENS INTO 4 SEGMENTS. THE SURGEON COMPLETED A ROUTINE PHACOEMULSIFICATION PROCEDURE AND IMPLANTED THE LENS INSIDE THE CAPSULAR BAG. THERE WAS NO VITREOUS PROLAPSE AND THE CHAMBER WAS STABLE THROUGHOUT THE CASE. HOWEVER, 3 DAYS POSTOPERATIVELY, THE SURGEON REPORTED THE INTRAOCULAR LENS (IOL) HAD SHIFTED. SECONDARY SURGICAL INTERVENTION WAS PERFORMED ON (B)(6) 2021 TO REPOSITION THE IOL. DURING THE INTERVENTION, THE SURGEON OBSERVED A POSTERIOR CAPSULAR TEAR THAT WAS NOT PREVIOUSLY OBSERVED; THE SURGEON SULCUS-FIXATED THE LENS AND PUSHED THE OPTIC INTO THE CAPSULAR BAG. THE PATIENT IS REPORTEDLY DOING WELL POST INTERVENTION. THE SURGEON REPORTS NO ADVERSE IMPACT ON VISION OR SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1448893 MILOOP LENS FRAGMENTATION DEVICE PHACOFRAGMENTATION UNIT HQC CARL ZEISS MEDITEC CATARACT TECHNOLOGY, INC. FG-50608

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention