BEUDAMED
    FDA Adverse Event Other Summary report: N

    PHACOEMULSIFICATION UNIT

    MDR report key: 10969 · Received January 18, 1994

    Report

    Report Number
    MW1000413
    Event Type
    Other
    Date Received
    January 18, 1994
    Date of Event
    December 8, 1993
    Report Date
    December 17, 1993
    Manufacturer
    ALCON SURGICAL, INC.
    Product Code
    HQC
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING PHACO PROCEDURE WITH THIS PIECE OF NEW EQUIPMENT (OBTAINED 11/93), EMULSIFICATION HANDPIECE DID NOT DELIVER FLUID FOR IRRIGATION, RESULTING IN BURN TO UNDERSIDE OF RIGHT CORNEA. NO TREATMENT REQUIRED, AND PT DISCHARGED TO HOME WITH APPOINTMENT FOR F/U WITH ATTENDING PHYSICIAN. IMMEDIATELY REPORTED TO MFR, WHO SCHEDULED VISIT FOR 12/13/93. VISIT INDICATED PROBLEM WAS RELATED TO USER UNFAMILIARITY WITH SPEED OF NEW EQUIPMENT. ALTHOUGH EVENT DID NOT REQUIRE INTERVENTION, BIOMEDICAL CONSULTANT ON 12/28/93 RECOMMENDED THAT THIS INFO WOULD BE VALUABLE FOR THE FDA TO KNOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHACOEMULSIFICATION UNIT HQC ALCON SURGICAL, INC. LEGACY 2000 HANDPIECE #91131HG

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other