BEUDAMED
    FDA Adverse Event Other Summary report: N

    AMERICAN OPTISURGICAL INC.

    MDR report key: 358181 · Received October 18, 2001

    Report

    Report Number
    MW1023192
    Event Type
    Other
    Date Received
    October 18, 2001
    Date of Event
    August 23, 2001
    Report Date
    October 10, 2001
    Manufacturer
    AMERICAN OPTISURGICAL INC.
    Product Code
    HQE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    "A KERATOME WAS USED TO MAKE A BEVELED INCISION INTO THE ANTERIOR CHAMBER USING A CYSTOTOME; ANTERIOR CAPSULOTOMY WAS THEN PERFORMED. NEXT PHACOEMULSIFICATION WAS INITIATED. THERE WAS SOME TECHNICAL DIFFICULTY WITH THE PHACOEMULSIFICATION AND NO ASPIRATION WAS NOTED AND THE PHACOEMULSIFICATION WAS NOT WORKING AT ALL. AT THIS TIME THE HANDPIECE WAS CHECKED AND RPTR IS NOT ABLE TO IRRIGATE THROUGH IT AND IT APPEARED TO BE BLOCKED. HANDPIECES WERE EXCHANGED, ALMOST WHEN THE TOTAL LENS WAS PHACOEMULSIFIED. IT WAS NOTED THAT THERE WAS WHAT APPEARED TO BE A CORNEAL BURN AT THE SITE OF THE INCISION WHICH WAS THOUGHT TO BE RELATED TO THE TECHNICAL DIFFICULTY WITH THE PHACOEMULSIFICATION INSTRUMENT." FROM POSTOPERATIVE REPORT DICTATED BY OPHTHALMOLOGIST AT 2234. PROCEDURE WAS COMPLETED AS USUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47069 AMERICAN OPTISURGICAL INC. PHACOEMULSIFICATION HANDPIECE HQE AMERICAN OPTISURGICAL INC. TURBOSONIC *

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other ALCON LEGACY 2000.