BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BVI VISITEC ANTERIOR CHAMBER CANNULA (RYCROFT)

    MDR report key: 7395510 · Received April 3, 2018

    Report

    Report Number
    MW5076312
    Event Type
    Injury
    Date Received
    April 3, 2018
    Date of Event
    February 28, 2018
    Report Date
    April 2, 2018
    Manufacturer
    BVI VISITEC
    Product Code
    HMX
    UDI-DI
    30886158002452
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE LEFT EYE WAS PREPPED AND DRAPED FOR OPHTHALMIC SURGERY AND SURGICAL PROCEDURE BEGAN. CATARACT EXTRACTION WAS PERFORMED AND IOL + 19.05 (B)(4) WAS INTRODUCED. DURING THE HYDRATION OF THE TEMPORAL WOUND, THE CANNULA DISCONNECTED FROM THE SYRINGE AND ENTERED THE ANTERIOR CHAMBER, BREAKING THE POSTERIOR CAPSULAR BAG. THIS CAUSED DISLOCATION OF THE IMPLANTED IOL WHICH THEN RECEDED INTO THE VITREOUS CAVITY. EYE WAS EVALUATED BY SURGEON, WOUNDS WERE RE-CHECKED AND NO ADDITIONAL PROCEDURE WAS REQUIRED AT THAT TIME. GATIFLOXACIN AND PREDNISOLONE DROPS WERE GIVEN PRIOR TO PATCHING. PATCH PLACED OVER SURGICAL SITE AND PATIENT TRANSFERRED TO POST-OP HOLDING AREA. ON RE-ASSESSMENT 2 DAYS LATER - THICK HEME OVERLYING THE MACULA AND OPTIC NERVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234167 BVI VISITEC ANTERIOR CHAMBER CANNULA (RYCROFT) CANNULA, OPHTHALMIC HMX BVI VISITEC 581273 3210649 30886158002452

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other