BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MST CAPSULE RETRACTOR

    MDR report key: 3851286 · Received March 26, 2014

    Report

    Report Number
    3019924-2014-00009
    Event Type
    Malfunction
    Date Received
    March 26, 2014
    Report Date
    March 25, 2014
    Manufacturer
    MICROSURGICAL TECHNOLOGY, INC.
    Product Code
    HNI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE COURSE OF INVESTIGATING THIS INCIDENT A SIMILAR ISSUE WAS IDENTIFIED AND WILL BE SUBMITTED ON REPORT NUMBER 3019924-2014-00010.

    Description of Event or Problem · 1

    DURING CATARACT SURGERY ON A PATIENT WITH LOOSE ZONULES, AN MST CAPSULE RETRACTOR WAS THREADED ONTO A CAPSULOR TENSION RING AND WAS NOT ABLE TO BE REMOVED FROM THE EYE. THE SURGEON CUT THE CAPSULE RETRACTOR CLOSE TO THE PERIPHERY AND TUCKED THE END OF THE RETRACTOR UNDER THE IOL AND REMOVED THE REMAINING PORTION OF THE RETRACTOR. POST-OP THE PATIENT WAS DOING WELL AND HEALING NORMALLY WITH THE PIECE OF RETRACTOR STILL BEHIND THE CENTERED IOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176534 MST CAPSULE RETRACTOR OPHTHALMIC RETRACTOR HNI MICROSURGICAL TECHNOLOGY, INC. MCR-0001

    Patients

    Seq Age Sex Outcome Treatment
    1