BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 8836591 · Received July 29, 2019

    Report

    Report Number
    2028159-2019-01387
    Event Type
    Injury
    Date Received
    July 29, 2019
    Date of Event
    January 1, 2019
    Report Date
    October 22, 2019
    Manufacturer
    ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    FLUID-AIR EXCHANGE (FAX) IS A TECHNIQUE AND STEP IN VITREORETINAL SURGERY AND IS PRIMARILY PERFORMED TO INTRODUCE AN INTRAOCULAR AIR BUBBLE WHICH ASSISTS THE SURGEON IN REATTACHING, FLATTENING AND/OR REPOSITIONING TORN OR DETACHED RETINAL TISSUE. THIS METHOD PROVIDES AIR, HAS A MUCH HIGHER FLOTATION FORCE, AND THEREFORE HAS A MORE TAMPONADE EFFECT ON RETINAL TISSUE THAN BALANCED SALT SOLUTION. THERE IS NO ADDITIONAL MEDICAL OR OCULAR HISTORY PROVIDED AND RELATED INFORMATION WAS NOT MADE AVAILABLE ON THIS REPORTED ISSUE. THEREFORE, THE REPORTED EVENT CANNOT BE CONCLUSIVELY DETERMINED. NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED FROM THIS CUSTOMER. WITH NO ADDITIONAL, RELATED INFORMATION PROVIDED, THE CUSTOMERS REPORTED EVENT WAS NOT ABLE TO BE CONFIRMED. THE MANUFACTURING DEVICE HISTORY RECORD (DHR) WAS REVIEWED. BASED ON QA ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. MASSIVE SUBRETINAL GAS AFTER VITRECTOMY SURGERY: MECHANISM AND MANAGEMENT; OPHTHALMIC COMMUNICATIONS SOCIETY, INC; RETINAL CASES AND BRIEF REPORTS 13:266-268, 2019. (B)(4).

    Description of Event or Problem · 1

    A LITERATURE ARTICLE REPORTS A PATIENT WHO UNDERWENT 23G PARS PLANA VITRECTOMY, SCLERAL BUCKLE, PHOTOCOAGULATION WITH GAS INSTALLATION FOR REPAIR OF A RETINAL DETACHMENT WITH THE MACULA OFF AND HORSESHOE TEAR, IN THE LEFT EYE. AT THE CONCLUSION OF THE SURGERY, GAS WAS INJECTED THROUGH THE PARS PLANA USING A 30G NEEDLE INTO THE VITREOUS CAVITY TO CORRECT HYPOTONY. THE PATIENT PRESENTED ON POSTOPERATIVE DAY ONE, WITH A SIGNIFICANT VOLUME OF SUBRETINAL GAS PUSHING THE RETINA ANTERIORLY AGAINST THE CRYSTALLINE LENS. THAT DAY, THE SUBRETINAL GAS WAS EVACUATED. THE AUTHORS DISCUSS POSSIBLE CAUSES: DURING GAS-EXCHANGE, IT IS POSSIBLE THAT THE JET STREAM OF GAS WAS DIRECTED TOWARD THE RETINAL BREAK, FORCING GAS INTO THE SUBRETINAL SPACE. HOWEVER, IN THE ABSENCE OF TRACTION, THIS SEEMS HIGHLY UNLIKELY. ALTERNATIVELY, THE INFUSION CANNULA COULD HAVE BEEN DISPLACED INTO THE SUPRACHOROIDAL SPACE, AND THUS, GAS COULD DETACH THE PARS PLANA AND DISSECT POSTERIORLY UNDER THE RETINA. FINALLY, IT IS POSSIBLE THAT THE NEEDLE DID NOT ENTIRELY PENETRATE THROUGH THE PARS PLANA, LEADING TO PNEUMATIC DISSECTION BETWEEN THE NONPIGMENTED AND PIGMENTED CILIARY BODY EPITHELIUM. THIS REPORT OUTLINES THE POSSIBLE MECHANISMS AND SURGICAL APPROACHES FOR THE MANAGEMENT OF A LARGE VOLUME OF SUBRETINAL GAS AFTER PARS PLANA VITRECTOMY. WHEN INJECTING GAS THROUGH THE PARS PLANA IN A HYPOTONOUS EYE, SURGEONS SHOULD BE VIGILANT IN ENSURING THAT THEIR NEEDLE IS WITHIN THE VITREOUS CAVITY BEFORE COMMENCING INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631921 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER LXT ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention 23G DISPOSABLE BACKFLUSH| 23G TROCAR| 30G NEEDLE| BSS| C3F8 GAS| 23G DISPOSABLE BACKFLUSH| 23G TROCAR| 30G NEEDLE| BSS| C3F8 GAS