BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE

    MDR report key: 4902648 · Received July 9, 2015

    Report

    Report Number
    3002037047-2015-00543
    Event Type
    Injury
    Date Received
    July 9, 2015
    Report Date
    October 2, 2015
    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
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLES WERE RETURNED FOR INVESTIGATION. THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT IS NOT KNOWN; NO SAMPLES WERE RETURNED FOR INVESTIGATION. (B)(4).

    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 ADDITION REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    AN ACCOUNT MANAGER WAS CONTACTED BY A SURGEON TO REPORT THAT THERE HAD BEEN TWO PATIENTS THAT HAD DEVELOPED ENDOPHTHALMITIS FOLLOWING A CATARACT EXTRACTION PROCEDURE. IT IS UNKNOWN WHETHER OR NOT THE PATIENTS REQUIRED TREATMENT OF ANY KIND. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447276 DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE AID, SURGICAL, VISCOELASTIC LZP ALCON - COUVREUR N.V./ALCON - BELGIUM NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other