BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1822550 · Received August 27, 2010

    Report

    Report Number
    2028159-2010-01588
    Event Type
    Injury
    Date Received
    August 27, 2010
    Report Date
    July 29, 2010
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER ORDERED A NEW CPC CONNECTOR. THE CUSTOMER REPLACED THE CPC CONNECTOR TO MITIGATE THE DIFFICULTY CONNECTING THE VITRECTOMY PROBE TO THE SYSTEM. THE REPLACED CPC CONNECTOR WAS DISPOSED OF. THE CUSTOMER CANCELED THE SERVICE REQUEST. 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. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "POSTERIOR CAPSULE TEAR" (CAPSULAR BAG TEAR, POSTERIOR). PRODUCT PROBLEM(S): 'VITRECTOMY PROBE WAS DIFFICULT TO CONNECT" (FITTING PROBLEM). THE NURSE REPORTED A POSTERIOR CAPSULE TEAR OCCURRED. THE NURSE STATED THE VITRECTOMY PROBE WAS DIFFICULT TO CONNECT TO THE SYSTEM. ADDITIONAL INFORMATION REC'D FROM THE NURSE STATED SHE WAS ABLE TO FORCE THE ANTERIOR VITRECTOMY PROBE CONNECTOR ON TO THE SYSTEM. THE ANTERIOR VITRECTOMY WAS COMPLETED. THE NURSE STATED THE POSTERIOR CAPSULE TEAR WAS A CASE COMPLICATION AND DID NO FAULT ANY ALCON PRODUCT.

    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 Required Intervention