BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 3477066 · Received November 5, 2013

    Report

    Report Number
    2028159-2013-02128
    Event Type
    Injury
    Date Received
    November 5, 2013
    Date of Event
    August 28, 2013
    Report Date
    October 10, 2013
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    HOSPITAL REPORTED THAT A PT EXPERIENCED ENDOPHTHALMITIS SECONDARY TO A 23-GAUGE EPIRETINAL MEMBRANE SURGERY WITH NO INJECTION OF AIR, GAZ OR SILICON AT THE END OF SURGERY ON (B)(6) 2013. THE EVENT OCCURRED ONE OR TWO DAYS POSTOPERATIVELY. HOSPITAL PHARMACIST ALSO REPORTED THAT THEIR STERILIZATION CIRCUIT HAD BEEN COMPUTERIZED IN (B)(6) 2013. ADDITIONAL INFO HAS BEEN REQUESTED. THIS IS ONE OF TEN REPORTS BEING FILED FOR THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570339 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC WITH LASER NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other