BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2161122 · Received June 17, 2011

    Report

    Report Number
    2028159-2011-00691
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Report Date
    May 18, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYS AND NO PROBLEMS WERE FOUND. THE SYS WAS THEN TESTED AND MET ALL PRODUCT SPECS. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADD'L SIMILAR REPORTS FOR THIS SYS. THE ROOT CAUSE IS UNK. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT DURING SURGERY, THE PHACO DID NOT WORK. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GATHER ADD'L INFO REGARDING HOW THE SURGERY WAS COMPLETED AND THE IMPACT ON THE PT, BUT NO INFO HAS BEEN PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK