BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2180906 · Received July 22, 2011

    Report

    Report Number
    2028159-2011-00850
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 22, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYSTEM AND NO PROBLEM WAS FOUND. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. NO SAMPLE WAS RETURNED FOR EVAL AND NO ADDITIONAL INFO WAS PROVIDED RELATING TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADDITIONAL SIMILAR REPORTS FOR THIS SYSTEM. THE ROOT CAUSE IS UNK AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED RUPTURED CAPSULES. A COMPLETED QUESTIONAIRE WAS RECEIVED REPORTING THAT THE SURGEON HAD RECENTLY SEEN MORE TEARS OCCURRING THAN HE HAD IN PREVIOUS MONTHS. THE QUESTIONAIRE INDICATED THAT VITRECTOMIES WERE DONE TO TREAT THE EVENTS. NO ADDITIONAL INFO OR PT IDENTIFIERS WERE PROVIDED. THIS IS THE SECOND OF TWO REPORTS BEING FILED FOR THIS FACILITY.

    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 Required Intervention DISCOVISC