BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 2031393 · Received March 23, 2011

    Report

    Report Number
    2028159-2011-00270
    Event Type
    Injury
    Date Received
    March 23, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 21, 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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE ROOT CAUSE IS UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED ON BEHALF OF A SURGEON THE FOLLOWING EVENTS: AFTER COMPLETING SILICONE OIL REMOVAL, THE SURGEON DOES A FLUID/AIR EXCHANGE TO HELP FACILITATE OIL DROPLET REMOVAL, AND THEN HE GOES BACK TO FLUID. WHEN HE WENT BACK TO FLUID, THE FLUID CAME BACK INTO THE EYE WITH SUCH FORCE THAT IT CAUSED A HOLE IN THE RETINA. FLUID ALSO GOT BEHIND THE RETINA INDUCING A DETACHMENT. THE EVENTS OCCURRED WHILE USING IOP CONTROL. 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 NI Required Intervention