BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSAL II

    MDR report key: 3820811 · Received May 8, 2014

    Report

    Report Number
    2028159-2014-00758
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    January 1, 2013
    Report Date
    April 10, 2014
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K911808
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    CLINICAL INVESTIGATION ON ANGLE-CLOSURE GLAUCOMA PATIENTS WITH CATARACT TREATED BY PHACOEMULSIFICATION COMBINED WITH TRABECULECTOMY, INT EYE SCI, VOL 13, NO. 11, NOV, 2013. 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

    A LITERATURE ARTICLE STATED THAT AFTER A PROCEDURE, MULTIPLE PATIENT'S EXPERIENCED CORNEAL EDEMA THAT NEEDED TREATMENT. IN ALL CASES, AFTER BEING TREATED WITH DROPS, THE CORNEAL EDEMA RESOLVED WITHIN A WEEK. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279623 UNIVERSAL II PHACOEMULSIFICATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER UNIV II NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention UNK.