BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSAL PEA

    MDR report key: 356192 · Received October 12, 2001

    Report

    Report Number
    2028159-2001-00306
    Event Type
    Injury
    Date Received
    October 12, 2001
    Report Date
    September 13, 2001
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    REPORTER NOTED CORNEAL BURN OCCURRED DURING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46009 UNIVERSAL PEA PHACOEMULSIFICATION-ASPIRATION SYSTEM HQE ALCON - IRVINE TECHNOLOGY CENTER UNIVERSAL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other