BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE

    MDR report key: 5070343 · Received September 11, 2015

    Report

    Report Number
    3002037047-2015-00555
    Event Type
    Injury
    Date Received
    September 11, 2015
    Date of Event
    June 19, 2015
    Report Date
    May 16, 2016
    Manufacturer
    ALCON - COUVREUR N.V./ALCON - BELGIUM
    Product Code
    LZP
    PMA / PMN Number
    P840064
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE HAS BEEN RECEIVED BY MANUFACTURING FOR EVALUATION. 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    ALL BATCHES ARE RELEASED ACCORDING TO THE REQUIRED SPECIFICATIONS AND ALL INITIAL TESTING RESULTS ARE WITHIN SPECIFICATION; ALL TESTING RESULTS WERE WITHIN SPECIFICATION FOR THIS BATCH. FOUR UNOPENED, SLIGHTLY DAMAGED CARTONS CONTAINING UNOPENED BLISTERS AND LEAFLET WERE RECEIVED. THE SAMPLES WERE NOT REFRIGERATED. OUR LAB HAS TESTED THE RETURNED SAMPLES AND ALL RESULTS ON THE COMPLAINT SAMPLES ARE CONFORM THE SPECIFICATIONS FOR THE TESTED PARAMETERS. AS THE RETURNED SAMPLES WERE CONFORMING AND ALL INITIAL TESTING RESULTS ARE WITHIN SPECIFICATION, A CONCLUSIVE ROOT CAUSE COULD NOT BE DETERMINED. BASED ON THE COMPLAINT INFORMATION AND THE INVESTIGATION RESULTS, WE CAN CONCLUDE THAT THE DISPOSITION OF THE PRODUCT REMAINS UNCHANGED. (B)(4).

    Description of Event or Problem · 1

    A DOCTOR REPORTED THAT A PATIENT PRESENTED WITH POSTOPERATIVE UVEITIS AFTER VISCOELASTIC PRODUCT WAS USED DURING THE PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602237 VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE AID, SURGICAL, VISCOELASTIC LZP ALCON - COUVREUR N.V./ALCON - BELGIUM NA 15A05I

    Patients

    Seq Age Sex Outcome Treatment
    1 Other