BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 1841622 · Received September 16, 2010

    Report

    Report Number
    2028159-2010-01760
    Event Type
    Injury
    Date Received
    September 16, 2010
    Date of Event
    August 17, 2010
    Report Date
    August 17, 2010
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K063583
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "CORNEAL EDEMA" (CORNEAL EDEMA): "POSTERIOR CAPSULE TEAR" (CAPSULAR AG TEAR, POSTERIOR). PRODUCT PROBLEM(S): "SYSTEM MESSAGE DISPLAYED" (DEVICE DISPLAYS ERROR MESSAGE). THE CUSTOMER REPORTED A SYSTEM MESSAGE DISPLAYED. BETWEEN THE SIXTH AND SEVENTH CASE THE SYSTEM SHUT DOWN. THE PT'S EYE HAD ALREADY BEEN PREPARED WITH IODINE. THE SYSTEM WAS SWITCHED OUT AND DUE TO THE EXTRA TIME, IT TOOK TO SWITCH TO THE OTHER SYSTEM, THE PT DEVELOPED CORNEAL EDEMA. THE SURGERY DID NOT GO WELL, AND A POSTERIOR CAPSULAR RUPTURE OCCURRED. ADDITIONAL INFO HAS BEEN REQUESTED ON THE PT STATUS.

    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 UNK Other INFINITI SYSTEM