BEUDAMED
    FDA Adverse Event Summary report: N

    PHARCOEMULSIFICATION CATARACT SYSTEM

    MDR report key: 15075 · Received July 29, 1994

    Report

    Report Number
    MW4000461
    Date Received
    July 29, 1994
    Date of Event
    May 31, 1994
    Report Date
    June 29, 1994
    Manufacturer
    SITE MICROSURGICAL SYSTEMS, INC.
    Product Code
    HQC
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    TWO INCIDENCES OF SIGNIFICANT CORNEAL SCLERAL THERMAL INJURIES ON SEQUENTIAL PTS ON 5/31/94. THE MORE SERIOUS INJURY WAS TO A MONOCULAR PT. BOTH CASES WERE OTHERWISE UNCOMPLICATED CATARACT PROCEDURES WITH SHORT PHACOEMULSIFICATION TIMES. IN BOTH CASES, AFTER REMOVAL OF THE PHACOEMULSIFICATION HANDPIECE FROM THE EYE, THE BURNED TISSUES WERE EVIDENT. THE HANDPIECES FOR EACH CASE WERE DIFFERENT. THE MACHINE HAS GENERATED OTHER THERMAL INJURIES OF LESSER EXTENT THAT RPTR THOUGHT WERE DUE TO OLD HANDPIECES WHICH WERE REPLACED EACH TIME THERE WAS EVIDENCE OF A THERMAL INJURY. IT IS APPARENT THAT THE PROBLEM IS NOT IN THE HANDPIECES. THE CO NO LONGER MFRS THIS PHACOEMULSIFICATION MODULE AND HANDPIECE BECAUSE THEY HAVE REDESIGNED A NEW MODULE AND HANDPIECE. IT IS THE EYE DEPARTMENT'S FEELING THAT THE CURRENT PHACOEMULSIFICATION CATARACT MACHINE IS NOT SAFE FOR PT USE AND SHOULD BE REPLACED AS SOON AS POSSIBLE. THE UNIT HAS BEEN SENT TO CO FOR A COMPLETE EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHARCOEMULSIFICATION CATARACT SYSTEM HQC SITE MICROSURGICAL SYSTEMS, INC. 501-1045

    Patients

    Seq Age Sex Outcome Treatment
    1 *