BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTURION VISION SYSTEM

    MDR report key: 2930410 · Received January 23, 2013

    Report

    Report Number
    2028159-2013-00046
    Event Type
    Injury
    Date Received
    January 23, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 24, 2012
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K121555
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT REQUEST SERVICE FOR THE SYSTEM. THERE WAS NO SAMPLE RETURNED FOR EVAL AND NO ADD'L INFO PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. A REVIEW OF COMPLAINT FOR THE LAST 24 MONTHS DID INDICATE ONE SIMILAR REPORT FOR THIS SYSTEM. THE ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT AT THE ONE POSTOPERATIVE VISIT FOLLOWING A CATARACT EXTRACTION PROCEDURE, HE NOTICED A SMALL NUCLEAR LENS FRAGMENT IN THE ANTERIOR CHAMBER OF THE PT. A SECOND PRODUCT WAS DONE TO REMOVE THE LENS MATERIAL WITH NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32473 CENTURION VISION SYSTEM PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention KELMAN PHACO TIP| BALANCE SAFT SOLUTION (BSS)| OZIL TORTIONAL PHACO HANDPIECE| VISCOAT