BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALCON SURGICAL, INC.

    MDR report key: 76284 · Received March 13, 1997

    Report

    Report Number
    76284
    Event Type
    Injury
    Date Received
    March 13, 1997
    Date of Event
    February 13, 1997
    Report Date
    March 10, 1997
    Manufacturer
    ALCON SURGICAL, INC.
    Product Code
    HQC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING THE COURSE OF A PHACO CE A CORNEAL BURN OCCURRED. THE HANDPIECE OVERHEATED. HANDPIECE WAS APPROX 1 YR OLD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALCON SURGICAL, INC. PHACOEMULSIFIER HQC ALCON SURGICAL, INC. IMHP063059 *

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention