BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IQ577

    MDR report key: 6211731 · Received December 28, 2016

    Report

    Report Number
    2939653-2016-00011
    Event Type
    Injury
    Date Received
    December 28, 2016
    Date of Event
    September 9, 2016
    Report Date
    September 13, 2016
    Manufacturer
    IRIDEX CORPORATION
    Product Code
    GEX
    PMA / PMN Number
    K071687
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE IQ577 AND SLA WERE RETURNED TO THE MANUFACTURER AND AN ANALYSIS WAS PERFORMED. THE UNITS WERE TESTED AND BOTH PERFORMED TO SPECIFICATIONS. THE POWER MEASUREMENTS WERE IN THE EXPECTED RANGE. SHOULD ADDITIONAL INFORMATION BE OBTAINED REGARDING THIS EVENT, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MANUFACTURER ON SEPTEMBER 13, 2016 THAT AN (B)(6) MALE PATIENT UNDERWENT A LASER PROCEDURE ON (B)(6) 2016 TO TREAT AGE RELATED MACULAR DEGENERATION (ARMD) USING AN IRIDEX IQ577 LASER. THREE DAYS POST PROCEDURE, THE PATIENT REPORTED A DECLINE IN VISION. THE PATIENT'S PRE-PROCEDURE VISUAL ACUITY WAS 20/60 +2. POST PROCEDURE, THE PATIENT'S VISUAL ACUITY WAS 20/70 -2. A FOLLOW UP APPOINTMENT ON (B)(6) 2016 REVEALED INCREASED SWELLING IN THE LEFT EYE. NO FURTHER FOLLOW UP INFORMATION HAS BEEN PROVIDED AT THE TIME OF THIS WRITING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858772 IQ577 LASER SYSTEM GEX IRIDEX CORPORATION IQ577

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Other SLIT LAMP ADAPTER (SLA)