BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 1822545 · Received August 27, 2010

    Report

    Report Number
    2028159-2010-01605
    Event Type
    Injury
    Date Received
    August 27, 2010
    Report Date
    July 29, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS WERE MADE FOR MORE INFORMATION WITH NO RESPONSE TO DATE. THE FACILITY DID NOT REQUEST SERVICE. NO SAMPLES WERE RETURNED FOR EVALUATION. THERE WAS NO SAMPLE RETURNED FOR EVALUATION AND NO ADDITIONAL INFORMATION PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT AND THE ROOT CAUSE IS THEREFORE UNKNOWN AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "SOFT EYE" (INTRAOCULAR PRESSURE, DELAYED, UNCONTROLLED). PRODUCT PROBLEM(S): "IOP FLUCTUATION" (PRESSURE ISSUE). THE SURGEON REPORTED THE IOP WAS FLUCTUATING "ALL OVER THE PLACE". THE SURGEON WAS NOT IN THE MIDDLE OF ANY INTERVENTION AT THE TIME. THE SURGEON WAS ABLE TO RESUME SURGERY. LATER, DURING THE SAME CASE WHILE PERFORMING A SCLERAL DEPRESSION THE EYE FELT SOFT DESPITE THE IOP READING OF 60. NO PATIENT INJURY WAS REPORTED.

    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