BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNSPECIFIED SYSTEM

    MDR report key: 3761086 · Received April 10, 2014

    Report

    Report Number
    2028159-2014-00441
    Event Type
    Injury
    Date Received
    April 10, 2014
    Date of Event
    March 11, 2014
    Report Date
    March 13, 2014
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    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 ADD'L REPORTABLE BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A CLINICAL APPLICATION SPECIALIST REPORTED A CAPSULAR TEAR DURING THE QUADRANT PHASE OF THE PHACO PROCEDURE AFTER THE COMPLETION OF THE LASER ASSISTED PROCEDURE. A VITRECTOMY WAS PERFORMED AND AN ANTERIOR CHAMBER IOL WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216243 UNSPECIFIED SYSTEM UNSPECIFIED SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention LENSX LASER