BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 2210355 · Received August 9, 2011

    Report

    Report Number
    2028159-2011-00950
    Event Type
    Injury
    Date Received
    August 9, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 8, 2011
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S COMPLAINT HISTORY WAS REVIEWED FOR THE PERIOD OF ONE YEAR; THIS IS A SECOND EVENT REPORTED FOR THIS ISSUE FOR THIS FACILITY. THERE ARE NO ADDITIONAL REPORTS AGAINST THIS FINISHED GOODS LOT. A REVIEW OF THE DHR (DEVICE HISTORY RECORD) INDICATED NO DEVIATIONS. THE PAK WAS BUILT PER SPECIFICATIONS. A ROOT CAUSE HAS NOT BEEN IDENTIFIED. INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS, IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT WHEN THE TROCAR PLUG WAS REMOVED FROM THE TROCAR UNDER AIR IRRIGATION, THE EYE COLLAPSED. AFTER THE PLUG WAS REPLACED, THE SITUATION RECOVERED SLOWLY. THE SITUATION OCCURRED AGAIN WHEN THE PHYSICIAN PERFORMED VITREOUS CUTTING AND "RETROPULSION." THE EYE RECOVERED WHEN THE CUSTOMER KNOCKED THE AUTO COCK, BUT THE IMPROVED INTRAOCULAR PRESSURE DID NOT LAST LONG. 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 UNK Required Intervention COMBINED PAK