BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 1052745 · Received May 23, 2008

    Report

    Report Number
    2028159-2008-00190
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Date of Event
    April 25, 2008
    Report Date
    April 25, 2008
    Manufacturer
    ALCON-IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K021566
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHACO HANDPIECE WAS NOT SENT IN FOR EVAL. THE VIDEO OF THE SURGERY WAS REVIEWED BY OUR CLINICAL STAFF. THE PT HAD A DENSE WHITE CATARACT. THERE WAS INSUFFICIENT DILATION PRIOR TO THE PARACENTESIS. THE SURGEON PERFORMED A SUCCESSFUL PARACENTESIS AND A CONTINUOUS CURVILINEAR CAPSULORHEXIS. A PRECHOPPER WAS USED TO DISSECT THE NUCLEUS WITH THE PHACO HANDPIECE. THE SURGEON USED THE PHACO CHOP TECHNIQUE TO EMULSIFY THE NUCLEUS. AS THE PROCEDURE PROGRESSED THE PUPIL BEGAN TO CONSTRICT AND THE IRIS PROLAPSED ANTERIORLY. DURING PHACO, LOOSE NUCLEAR PARTICLES FLOATED INTO THE ANTERIOR CHAMBER. LOOSE PARTICLES TYPICALLY OCCUR DURING PHACO, DUE TO A LARGE PARACENTESIS OF THE MAIN INCISION, OR SOMETIMES THE SIDE PORT INCISION. THIS IS DUE TO A CHANGE IN FLUID FLOW, WHICH CAUSES THE PARTICLES TO FLOAT RATHER THAN STAY IN OCCLUSION WITH THE PHACO TIP,. SIGNIFICANT LENS MILKING WAS ALSO OBSERVED, CAUSED BY A CONTINUOUS TRANSVERSAL MOTION OF THE TIP. THIS PREVENTS THE EMULSIFIED MILK FROM ESCAPE THROUGH A CONSTANTLY OCCLUDED TIP. UPON REMOVAL OF THE PHACO HANDPIECE, THE IRIS APPEARED TO PROLAPSE THROUGH THE MAIN INCISION SITE. THE SURGEON ATTEMPTED TO FLATTEN THE IRIS TO AVOID CONTACT OF THE PHACO HANDPIECE WITH THE IRIS DURING INSERTION. THE PUPIL DILATED WHILE THE OVD (OPHTHALMIC VISCOSURGICAL DEVICE) WAS INSERTED INTO THE SITE. HOWEVER, THE VISCOMYDRIASIS (DILATION DUE TO OVD) WAS SHORT LIVED. DURING THE OVD INSERTION, THE CANNULA HIT THE IRIS THROUGH THE MAIN INCISION SITE, CREATING MORE IRIS TRAUMA. THE SURGEON SUCCESSFULLY TESTED THE FLUIDICS AND THE PHACO POWER OUTSIDE OF THE EYE, AND ATTEMPTED TO PROCEED WITH PHACO WHILE THE PUPIL CONTINUED TO CONSTRICT AND THE IRIS FURTHER PROLAPSED. THE SURGEON USED HIGH FLOW PHACO WITH OVER 100 ON THE IRRIGATION SETTING AND 300 ON THE VACUUM SETTING. THEREFORE, THE CONCLUSION DRAWN WAS THAT THE IRIS CHAFING OCCURRED DUE TO IRIS CONFIGURATION CHANGES, ALONG WITH PUPILLARY CONSTRICTION DURING PHACO. A REVIEW OF COMPLAINTS FOR THE LAST 36 MONTHS DID NOT INDICATE ADVERSE TRENDS FOR THE REPORTED ISSUE.

    Description of Event or Problem · 1

    THE DOCTOR REPORTED IRIS CHAFING WHILE USING THE PHACO HANDPIECE. NO ADDITIONAL INFO WAS PROVIDED. A VIDEO OF THE SURGERY WAS PROVIDED BY THE CUSTOMER. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN MORE INFO ON THE EVENT, AND PT STATUS, WITH NO RESPONSE TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFINITI VISION SYSTEM OPHTHALMIC SURGERY SYSTEM HQC ALCON-IRVINE TECHNOLOGY CENTER INFINITI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other