BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALCON LABORATORIES

    MDR report key: 655972 · Received December 16, 2005

    Report

    Report Number
    655972
    Event Type
    Injury
    Date Received
    December 16, 2005
    Date of Event
    November 1, 2005
    Report Date
    November 21, 2005
    Manufacturer
    ALCON MANUFACTURING, LTD.
    Product Code
    HQC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE MACHINE WAS PRIMED AND TUNED AND TESTED BY THE PHYSICIAN PRIOR TO INSERTION INTO THE PATIENT'S EYE. THE MACHINE WAS ON SCULPT AND THE DOCTOR MADE A FEW PASSES INTO THE LENS BEFORE THE MACHINE "FROZE UP" WITH NO INFLOW OR ASPIRATION. AN ATTEMPT TO REPRIME THE MACHINE WAS UNSUCCESSFUL. WHEN AN ATTEMPT WAS MADE TO RE-BOOT THE MACHINE THE SCREEN "FROZE." PATIENT REQUIRED A VITRECTOMY. A SECOND MACHINE WAS USED TO FINISH THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALCON LABORATORIES INFINITI PHACO-EMULSIFIER HQC ALCON MANUFACTURING, LTD. INFINITI *

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention