BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 2800936 · Received October 18, 2012

    Report

    Report Number
    2028159-2012-01614
    Event Type
    Injury
    Date Received
    October 18, 2012
    Date of Event
    September 18, 2012
    Report Date
    September 18, 2012
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A COMPANY REP REPORTED MULTIPLE SYSTEM MESSAGES DURING A CATARACT EXTRACTION PROCEDURE. IT WAS NOTED, IF A RESIDUAL LAYER OF BUBBLES REMAINED ON TOP OF THE FLUID IN THE VACUUM CHAMBER, THOSE BUBBLES WOULD REACH THE TOP OF THE OPTICAL SENSOR AND CAUSE THE SYSTEM MESSAGE. IT WAS ALSO REPORTED; THE PT HAD A POSTERIOR CAPSULE TEAR DURING THE PROCEDURE. THE SURGEON PUT IN AN ANTERIOR CHAMBER LENS. THE PROCEDURE WAS COMPLETED WITH NO FURTHER HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CTR LXT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention 0.9 ANTERIOR PAK