BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STELLARIS 25G COMBINED VITRECTOMY PACK

    MDR report key: 1940697 · Received December 22, 2010

    Report

    Report Number
    1920664-2010-00219
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 30, 2010
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQE
    PMA / PMN Number
    K063331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING THE POSTERIOR PORTION OF A COMBINED PHACO/POSTERIOR PROCEDURE, THE IRRIGATION LINES WERE CHANGED AND THE VALVE AT THE TOP OF THE LINE WAS LEFT IN THE CLOSED POSITION, RESULTING IN A COMPLETE LACK OF IRRIGATION. THE SURGEON DID NOT NOTICE THE LACK OF IRRIGATION AND PROCEEDED INTO THE POSTERIOR CHAMBER CAUSING THE GLOBE TO COLLAPSE. AT THAT POINT, THE STAFF DISCOVERED THE CLOSED VALVE AND THE VALVE WAS THEN OPENED TO ALLOW IRRIGATION. AFTER THE GLOBE WAS INFUSED, THE SURGEON DID NOT IDENTIFY THAT ANY INJURY HAD OCCURRED, BUT MADE THE DECISION TO ABORT THE PROCEDURE. DURING A SUBSEQUENT POST-OP VISIT ON (B)(6) 2010, THE PT WAS FOUND TO HAVE A RETINAL SEPARATION AND A CHOROIDAL HEMORRHAGE. HE EXTENT OF THE INJURY AND THE TYPE OF THE TREATMENT REQUIRED IS UNK AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STELLARIS 25G COMBINED VITRECTOMY PACK HQE BAUSCH & LOMB NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other