BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 2945056 · Received February 4, 2013

    Report

    Report Number
    2028159-2013-00144
    Event Type
    Injury
    Date Received
    February 4, 2013
    Report Date
    January 9, 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
    TD
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S COMPLAINT HISTORY WAS REVIEWED FOR THE PERIOD OF ONE YEAR; THIS IS ONE OF TWO COMPLAINTS REPORTED FOR THIS ISSUE. AS THE CUSTOMER DID NOT RETAIN THE FINISHED GOODS LOT NUMBER, DEVICE HISTORY RECORD (DHR) AND LOT HISTORY COULD NOT BE REVIEWED. THE CUSTOMER DID NOT RETAIN A SAMPLE FOR THIS COMPLAINT REPORT; VISUAL INSPECT OR FUNCTIONAL TESTING COULD NOT BE CONDUCTED. THE ROOT CAUSE IS UNKNOWN. WITHOUT A SAMPLE, IT IS NOT POSSIBLE TO ISOLATE THE ROOT CAUSE. (B)(4).

    Description of Event or Problem · 1

    AN OPHTHALMOLOGIST REPORT "NOTHING TEARS ON PATIENTS' DESCEMET'S MEMBRANE" AFTER PHACOEMULSIFICATION AND CATARACT REMOVAL, PRIOR TO INTRAOCULAR LENS (IOL) INSERTION. THE SURGEON REPORTED THAT HE HAS NOT MADE ANY CHANGES IN HIS TECHNIQUE, AND HE BELIEVES THE CAUSE IS EITHER THE TIP OR SLEEVE USED DURING THE PROCEDURES. THE PROCEDURES WERE COMPLETED. THERE WAS A REPORTED DELAY OF TWO DAYS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46286 INFINITI VISION SYSTEM PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MICROSMOOTH SLEEVE| KELMAN TIP