BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 3142991 · Received May 30, 2013

    Report

    Report Number
    2028159-2013-01047
    Event Type
    Injury
    Date Received
    May 30, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 6, 2013
    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
    NV, US
    Reporter Occupation
    NURSE

    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 ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A PATIENT PRESENTED WITH TASS (TOXIC ANTERIOR SEGMENT SYNDROME) 24 HOURS FOLLOWING A CATARACT EXTRACTION PROCEDURE, IN THE RIGHT EYE. IT WAS ALSO NOTED THAT THE PATIENT EXPERIENCED FLOATERS, FOGGINESS, AND REDNESS. THE PATIENT WAS TREATED WITH STEROID AND ANTIBIOTIC DROPS. THE CUSTOMER INDICATED ADDITIVES WERE INTRODUCED INTO THE BSS (BALANCED SALT SOLUTION) USED FOR THE PROCEDURE. IN THE SURGEON'S OPINION, THE ROOT CAUSE IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238413 INFINITI VISION SYSTEM PHACOFRAGMENTATION SYSTEM HQC ALCON- IRVINE TECHNOLOGY CENTER INFINITI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention MONARCH III CARTRIDGE D| TIMOLOL| TIMOPTIC| VANCOMYCIN| SN60WF| OZIL TORSIONAL PHACO HANDPIECE| DUOVISC| BSS| DUOVISC| TETRACAINE 0.5%| PHENYLEPHRINE 2.5 %| TROPICAMIDE 1%| CIPROFLOXIN| BETADINE 5%| KETORLAC 0.5%