BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 3669518 · Received February 7, 2014

    Report

    Report Number
    2028159-2014-00195
    Event Type
    Injury
    Date Received
    February 7, 2014
    Report Date
    January 14, 2014
    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
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. CITATION: DOORS M, TOS T, BERENDSCHOT JM, TOUWSLAGER W, WEBERS C, NUJITS R. JAMA OPHTHALMOL 2013; 131(11): 1443-1450. (B)(4).

    Description of Event or Problem · 1

    THE AUTHORS OF A LITERATURE REPORT AIMED AT COMPARING CORNEAL THICKNESS AND CORNEAL VOLUME CHANGES USING TORSIONAL AND LONGITUDINAL PHACOEMULSIFICATION IN PATIENTS WITH FUCHS ENDOTHELIAL DYSTROPHY (FED) REPORTED AN EYE IN THE LONGITUDINAL GROUP NEEDED ONE SUTURE TO CLOSE THE MAIN INCISION BECAUSE OF THERMAL INJURY OF THE CORNEA. THE EYE HAD A LOCS II GRADE 3 NUCLEUS WITH A CUMULATIVE DISSIPATED ENERGY AND ULTRASOUND TIME COMPARABLE WITH OTHERS IN THE LOCS II GRADE 3 GROUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78697 INFINITI VISION SYSTEM PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 45 DEGREES MINI FLARED KELMAN TIP| 0.9 MM ULTRA SLEEVE| INTREPID FMS