BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 2231181 · Received August 26, 2011

    Report

    Report Number
    2028159-2011-00997
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    July 26, 2011
    Report Date
    July 27, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K063583
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S COMPLAINT HISTORY WAS REVIEWED FOR THE PERIOD OF ONE YEAR; THIS IS SECOND EVENT REPORTED FOR THIS ISSUE FOR THIS FACILITY. THERE ARE NO ADDITIONAL REPORTS AGAINST THIS FINISHED GOODS LOT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) INDICATED NO DEVIATIONS. THE PAK WAS BUILT PER SPECIFICATIONS. THE ROOT CAUSE IS UNKNOWN AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED HAVING DIFFICULTY PRIMING SYSTEM PRIOR TO CATARACT EXTRACTION AND VITRECTOMY PROCEDURE. DURING THE VITRECTOMY, THE PATIENT'S EYE COLLAPSED. THE PRESSURE WAS RECOVERED AND THE CASE WAS COMPLETED AFTER TURNING OFF THE IOP CONTROL. CURRENT PATIENT STATUS IS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSTELLATION WITH LASER UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER CONSTELLATION NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other CONSTELLATION 25+ GA STRATEGIC PAK