BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUOVISC UNKNOWN

    MDR report key: 1891063 · Received October 29, 2010

    Report

    Report Number
    1119421-2010-01208
    Event Type
    Malfunction
    Date Received
    October 29, 2010
    Date of Event
    September 28, 2010
    Report Date
    September 29, 2010
    Manufacturer
    ALCON - BELGIUM/S.A. ALCON-COUVRERUR N.V.
    Product Code
    LZP
    PMA / PMN Number
    P840064
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. BATCH RECORD REVIEW SHOWED THAT ALL TESTING RESULTS ARE WITHIN SPECIFICATION. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FOR THIS LOT. RETENTION SAMPLES OF THIS BATCH WERE TESTED AND ALL RESULTS CONFORMED TO THE SPECIFICATIONS FOR THE TESTED PARAMETERS. RETURNED UNOPENED SAMPLES WERE TESTED AND ALL RESULTS CONFORMED TO THE SPECIFICATIONS FOR THE TESTED PARAMETERS. ADDITIONAL INFO WAS REQUESTED 09/29/2010 AND 10/01/2010 BY PHONE. (B)(4).

    Description of Event or Problem · 1

    A PHARMACIST REPORTED SURGEON NOTED PARTICLES IN FOUR PATIENTS EYES, WITH THE AID OF A MICROSCOPE, AFTER PRODUCT INSTILLATION. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUOVISC UNKNOWN AID, SURGICAL, VISCOELASTIC LZP ALCON - BELGIUM/S.A. ALCON-COUVRERUR N.V. NA 10C10U

    Patients

    Seq Age Sex Outcome Treatment
    1