BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MST PACKER CHANG IOL CUTTER

    MDR report key: 14247427 · Received April 29, 2022

    Report

    Report Number
    3019924-2022-00002
    Event Type
    Injury
    Date Received
    April 29, 2022
    Date of Event
    March 29, 2022
    Report Date
    April 28, 2022
    Manufacturer
    MICROSURGICAL TECHNOLOGY INC.
    Product Code
    HNF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FACILITY REPORTED THAT THE SCISSOR WOULD NOT CLOSE PROPERLY AFTER EXPLANTING AN IOL CAUSING WOUND DAMAGE WHEN REMOVING IT FROM THE EYE. THE EVALUATION OF THE RETURNED DEVICE SHOWED SIGNS OF BEING USED TO CUT A HARD OBJECT RESULTING IN SOME BLADE DAMAGE HOWEVER, THE SCISSOR ACTUATED CORRECTLY. THE REPORT OF THE SCISSOR NOT CLOSING PROPERLY COULD NOT BE CONFIRMED. THE PATIENT WAS REPORTED AS "EVERYTHING LOOKS GOOD" DURING SUBSEQUENT FOLLOW UP.

    Description of Event or Problem · 0

    DURING DESCEMET'S MEMBRANE ENDOTHELIAL KERATOPLASTY AND IOL EXCHANGE, THE SCISSOR MALFUNCTIONED AND CAUSED TISSUE DAMAGE UPON REMOVAL FROM THE EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100173 MST PACKER CHANG IOL CUTTER OPHTHALMIC SCISSORS HNF MICROSURGICAL TECHNOLOGY INC. DFH-0012 148757

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other