BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 1051363 · Received May 9, 2008

    Report

    Report Number
    2028159-2008-00167
    Event Type
    Injury
    Date Received
    May 9, 2008
    Date of Event
    April 11, 2008
    Report Date
    April 11, 2008
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K021566
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RECEIVED ONE PAGE OF 3500A FROM CUSTOMER. THE REPORTER WAS CONTACTED FOR THE MISSING INFO, BUT HAS NOT RESPONDED TO DATE. THE SAMPLE HAS BEEN REQUESTED FOR EVAL. THE RISK MANAGER HAS DECLINED TO SEND THE SAMPLE FOR IN-HOUSE EVAL. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER INITIALLY REPORTED THAT DURING THE CASE, THE STUDENT FIRST ASSIST, IN TRAINING TO SCRUB FOR THE SURGEON, DISCONNECTED AND WRONGLY RE-CONNECTED THE TUBING TO THE ANTERIOR VITRECTOMY PROBE. THIS CAUSED THE PROBE TO MALFUNCTION, AND RESULTED IN A SURGE EFFECT IN THE EYE. ADDITIONAL INFO RECEIVED FROM THE SURGEON STATED THERE WAS A POSTERIOR CAPSULE TEAR THAT WAS GREATLY ENLARGED BY THE IMMEDIATE INFLUX OF WHAT HE ESTIMATES TO BE ABOUT 10CC OF AIR. THIS WAS DUE TO THE FACT THAT THE STUDENT FIRST ASSIST RE-CONNECTED THE TUBING (WHICH HAD FALLED OFF) TO THE VITRECTOR INCORRECTLY. HE SAID THAT HE WAS NOT EVEN TOLD THAT THE TUBING HAD BECOME DISCONNECTED. THE FORCE OF THE AIR SENT THE IMPLANTED IOL TO THE BACK OF THE EYE, AND A LARGE AMOUNT OF VITREOUS CAME GUSHING OUT. HE MANAGED TO REPOSITION THE IOL SATISFACTORILY AND DID AN ANTERIOR VITRECTOMY. THE SURGEON STATED THAT THE PT IS NOW SEEING 20/50 IN THE OPERATED EYE, AND THERE IS NO EVIDENCE OF A RETINAL TEAR/DETACHMENT. ADDITIONAL INFO STATED THE SURGEON HAS SEEN THE PT, AND THAT SHE IS SEEING 20/25-2 UNCORRECTED FROM THE OPERATED EYE. THE SURGEON NOTED SOME CORTEX IN THE GEL, AND THAT THE IOL IS SUCCESSFULLY IMPLANTED IN THE SULCUS. THE PT IS DOING WELL.

    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 85 YR Required Intervention| S