BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIPLOMAX

    MDR report key: 85949 · Received June 20, 1996

    Report

    Report Number
    85949
    Event Type
    Injury
    Date Received
    June 20, 1996
    Date of Event
    May 23, 1996
    Report Date
    May 30, 1996
    Manufacturer
    ALLERGAN MEDICAL OPTICS
    Product Code
    HQC
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TUBING WAS REVERSED THROUGH PORTS ON MACHINE. FUNCTION TESTING AFTER SETUP DID NOT INDICATE A PROBLEM. WHEN THE EQUIPMENT WAS USED DURING THE PROCEDURE, THE PORTS WORKED IN REVERSE. THE PT EXPERIENCED A RENT IN THE POSTERIOR CAPSULE CAUSING THE NUCLEUS TO BE DISPLACED INTO THE RETINA. THIS NECESSITATED A SUBSEQUENT PARS PLANA VITRECTOMY. IT WAS LATER DISCOVERED THAT THE INSTRUCTIONS FOR CLAMPING THE TUBING WERE INCORRECT AS TO LOCATION. THE MACHINE ONLY FAIL SAFE ALARMED IF CLAMPED ON TUBING LEADING DIRECTLY TO THE HAND PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIPLOMAX PHACOEMULSIFICATION MACHINE HQC ALLERGAN MEDICAL OPTICS 41-01-01-7 *

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention