BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALCON LABORATORIES, INC.

    MDR report key: 292862 · Received August 25, 2000

    Report

    Report Number
    MW1019791
    Event Type
    Injury
    Date Received
    August 25, 2000
    Date of Event
    June 27, 2000
    Report Date
    August 16, 2000
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    HQE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PHACOEMULSIFICATION POSTERIOR CHAMBER LENS IMPLANT. ANTERIOR VITRECTOMY. MD STATES THAT HANDPIECE WAS NOT FUNCTIONING PROPERLY AND HAD TO BE CHANGED AND REINTRODUCED WHICH TILTED THE LENS ON THE TEMPORAL SIDE OF THE CAPSULAR SUPPORT. PT SENT TO OTHER FACILITY FOR SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALCON LABORATORIES, INC. MACKOOL ULTRASONIC HANDPIECE AND FOOTSWITCH HQE ALCON LABORATORIES, INC. IKHP003075 *

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention