BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHIRON SITE TXR

    MDR report key: 85806 · Received June 28, 1996

    Report

    Report Number
    85806
    Event Type
    Injury
    Date Received
    June 28, 1996
    Date of Event
    April 16, 1996
    Report Date
    April 18, 1996
    Manufacturer
    CHIRON VISION CORP
    Product Code
    HQC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING 2ND PASS OF PHACO EMULSIFICATION AT 16 SECONDS, A WHITE SPOT WAS NOTED TO BE FORMING OVER THE TUNNEL OF THE LIMBUS; IRRIGANT FLOWING FREELY PRIOR TO ENTRY AND AFTER REMOVAL; HANDPIECE CHANGED; ON 2ND PASS WITH THIS A BROWNISH DISCOLORATION WAS NOTED OVER THE PREVIOUS WHITE SPOT AT THE LIMBUS; MACHINE CHANGED, HANDPIECE CHANGED; AS THRER HAD BEEN APPARENT SHRINKAGE OF COLLAGEN IN THE TUNNEL, PROCEDURE CONVERTED TO A EXTRACAPSULAR WITH NO FURTHER DIFFICULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHIRON SITE TXR DIAPHRAGM SYSTEM PHACO EMULSIFICATION HQC CHIRON VISION CORP 501-1045 *

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention