BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOVEREIGN SYSTEM

    MDR report key: 2253970 · Received September 14, 2011

    Report

    Report Number
    2020664-2011-00062
    Event Type
    Injury
    Date Received
    September 14, 2011
    Date of Event
    July 27, 2011
    Report Date
    August 16, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQC
    PMA / PMN Number
    K981116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE SYSTEM WAS EVALUATED BY A FIELD SERVICE ENGINEER ON 8/25/2011, IT PASSED AND MET AMO STANDARDS. THE CUSTOMER HAS NOT RETURNED THE HANDPIECE THAT WAS USED IN PATIENT'S SURGICAL PROCEDURE. THE CUSTOMER ADVISED THAT THE HANDPIECE WILL NOT BE MADE AVAILABLE FOR INVESTIGATION UNLESS PATIENT TAKES ACTION THAT WARRANTS SO. AS OF 12/26/2011 AND 1/26/2012, ALTHOUGH REQUESTS WERE MADE OF THE CUSTOMER, THERE HAS BEEN NO UPDATES ON PATIENT'S SURGICAL OUTCOME OR INITIATION OF LEGAL ACTION ON THE PART OF THE PATIENT. THE CUSTOMER STATED THAT THEY WILL KEEP US INFORMED. SHOULD ADDITIONAL INFORMATION BE PROVIDED THAT CHANGES THE INFORMATION ALREADY PROVIDED BY AMO, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION IS STILL IN PROGRESS AND A SUPPLEMENTAL WILL BE SUBMITTED. AMO CONCOMITANT PRODUCTS USED DURING THE PROCEDURE: VITRECTOMY HANDPIECE, (B)(4), TIP MODEL: DIPLOMAT VITRECTOMY.

    Description of Event or Problem · 1

    SURGEON REPORTED THAT VACUUM STAYED ON WHEN PHACO HANDPIECE WAS REMOVED WHICH CAUSED PT AN INADVERTENT IRIDECTOMY. F/U WITH AMO REP INDICATED THAT PT LOST ABOUT 80% OF THE IRIS. THE SCLERAL WOUND WAS CLOSED WITH 7 SUTURES. POST-OPERATIVE REPORTED RESIDUAL BLOOD IN ANTERIOR CHAMBER WHICH IS CONTRIBUTING TO SOME VISION LOSS. VISION LOSS ANTICIPATED TO BE TEMPORARY AND MAY RETURN AFTER DISSIPATION OF RESIDUAL BLOOD. ADD'L POST-OPERATIVE THERAPY WILL REQUIRE FREQUENT OFFICE VISITS. EXPECTED PT OUTCOME AT THIS TIME IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOVEREIGN SYSTEM HQC ABBOTT MEDICAL OPTICS RSOV680300

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR