BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 3771007 · Received December 18, 2013

    Report

    Report Number
    2028159-2013-02420
    Event Type
    Injury
    Date Received
    December 18, 2013
    Date of Event
    November 28, 2013
    Report Date
    December 2, 2013
    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 Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT THERE WAS A LACK OF FLUID/AIR EXCHANGE DURING A VITRECTOMY PROCEDURE ON THE LEFT EYE. ONE DAY POSTOPERATIVE, THE PATIENT EXPERIENCED BLEEDING IN THE ANTERIOR CHAMBER. PT WAS OPERATED ONCE AGAIN. PT WAS HOSPITALIZED. DURING HOSPITALIZATION, DORZOLAMIDE AND TROXERUTIN WERE PRESCRIBED. SYMPTOMS ARE IMPROVING. OUTCOME OF EVENT IS UNK, PROGNOSIS IS UNK. IN SURGEON'S OPINION, THE DEVICE CONTRIBUTED TO THE EVENT: THE SURGEON TRIED SEVERAL TIMES TO PERFORM THE FLUID/AIR EXCHANGE WHICH LED TO HYPOTONY AND SUBSEQUENTLY TO THE POSTOPERATIVE BLEEDING IN THE ANTERIOR CHAMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664067 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CTR LXT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 CUSTOM PAK| PAK, PRM 23 5.0 CPM