BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 1132619 · Received August 22, 2008

    Report

    Report Number
    2028159-2008-00303
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    July 23, 2008
    Report Date
    July 27, 2008
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR.
    Product Code
    HQC
    PMA / PMN Number
    K021566
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REP EXAMINED THE SYS AND COULD NOT DUPLICATE THE PROBLEM. THE SYS WAS TESTED AND MET ALL PROD SPECIFICATIONS. A REVIEW COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADD'L REPORTS FOR THIS SYS. THE ROOT CAUSE OF THE PT EVENT CANNOT BE DETERMINED IN THIS INVESTIGATION. POSTERIOR CAPSULE TEAR IS AN ISSUE THAT IS OCCASIONALLY REPORTED WITH CATARACT SURGERY. HOWEVER, A REVIEW OF THE COMPLAINT TRENDS SHOWS THAT THE FREQUENCY REPORTED IS WITHIN KNOWN LEVELS FOR THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED 2 POSTERIOR CAPSULE TEARS OCCURRED. THE SURGEON STATED HE HAD DIFFICULTIES WITH THE CHAMBER SHALLOWING. THE EVENT DID NOT SEEM TO BE TRIGGERED BY ANY PARTICULAR ACTION AND THERE WERE NO SYS MESSAGES DISPLAYED. NO SINGLE USE ITEMS WERE RE-USED. PT OUTCOME IS UNK; ADD'L INFO HAS BEEN REQUESTED. THE SURGEON STATED HE WOULD COMPLETE THE QUESTIONNAIRE, BUT IT HAS NOT BEEN RETURNED TO DATE.

    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 DISCO VISC