BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 1132620 · Received August 22, 2008

    Report

    Report Number
    2028159-2008-00299
    Event Type
    Injury
    Date Received
    August 22, 2008
    Report Date
    July 23, 2008
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR.
    Product Code
    HQC
    PMA / PMN Number
    K021566
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SVC REP EXAMINED THE SYSTEMS AND CONFIRMED THERE WAS DIFFICULTY CONNECTING THE VITRECTOMY PROBE. THE VITRECTOMY CONNECTOR WAS REPLACED. THE SYSTEMS WERE BOTH THEN TESTED AND FOUND TO MEET ALL PROD SPECIFICATIONS. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADD'L REPORTS FOR EITHER SYS REFERENCED IN THIS COMPLAINT NOR DID IT INDICATE ADVERSE TRENDS FOR THE REPORTED EVENT. THERE WERE NO SAMPLES RETURNED FOR EVAL, AND NO ADD'L INFO PROVIDED BY THE CUSTOMER. FOR THIS REASON, THERE IS INSUFFICIENT INFO TO REPLICATE OR CONFIRM THE REPORTED PT EVENT AND THE ROOT CAUSE IS THEREFORE UNK AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED TO REPORT THE ANTERIOR VITRECTOMY PROBE WAS DIFFICULT TO CONNECT TO THE SYS. THE CUSTOMER WOULD NOT CONFIRM OR DENY IF A POSTERIOR CAPSULE TEAR OCCURRED AND OR IF THE ANTERIOR VITRECTOMY WAS PLANNED. THE CUSTOMER DECLINED TO COMPLETE A QUESTIONNAIRE OR TO RELEASE ANY INFO ON THE EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Disability