BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1781221 · Received July 29, 2010

    Report

    Report Number
    2028159-2010-01328
    Event Type
    Malfunction
    Date Received
    July 29, 2010
    Report Date
    June 30, 2010
    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
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "NO PATIENT HARM/INJURY." (NO CONSEQUENCES OR IMPACT TO THE PATIENT). PRODUCT PROBLEM(S): "HANDPIECE PHACO DID NOT WORK WHEN IN EYE." (DEVICE INOPERABLE). A CUSTOMER REPORTED THERE WAS NO PHACOEMULSIFICATION DURING SURGERY. THE HANDPIECE WAS TUNED, BUT WHEN THE HANDPIECE WAS INSERTED INTO THE PATIENT'S EYE, THERE WAS NO PHACOEMULSIFICATION. THE HANDPIECE WAS TAKEN OUT OF THE PATIENT'S EYE AND TESTED IN A CUP OF WATER AND IT WORKED WELL. SINCE IT WORKED IN THE CUP OF WATER, THE HANDPIECE WAS AGAIN INSERTED INTO THE EYE BUT AGAIN, NO PHACOEMULSIFICATION. THE HANDPIECE WAS THEN REPLACED WITH ANOTHER ONE AND THE SURGERY WAS COMPLETED WITHOUT ANY COMPLICATIONS. THERE WAS A 5 MINUTE DELAY WHILE THE OTHER HANDPIECE WAS TUNED. THERE WAS NO PATIENT INJURY REPORTED.

    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