BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISCOAT

    MDR report key: 1243060 · Received November 21, 2008

    Report

    Report Number
    3002037047-2008-00098
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 23, 2008
    Manufacturer
    ALCON - BELGIUM / S.A. ALCON-COUVREUR N.V.
    Product Code
    LZP
    PMA / PMN Number
    P840064
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. BATCH RECORD REVIEW INDICATED PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO SIMILAR COMPLAINTS REPORTED IN THIS LOT NUMBER EXCEPT BY THIS FACILITY. ADDITIONAL INFORMATION WAS REQUESTED ON 10/23/2008 BY FAX AND MAIL AND ON 11/11/2008 BY PHONE. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    A FACILITY REPORTED TWO OUT OF FOUR PATIENTS WHO HAD SURGERY IN 2008 EXPERIENCED CORNEAL EDEMA. BOTH PATIENTS WERE TREATED WITH TOPICAL MEDICATION; NO ADDITIONAL PROCEDURES REQUIRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS BEING FILED FOR THIS REPORT--THIS REPORT IS FOR THE MALE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISCOAT AIR, SURGICAL, VISCOELASTIC LZP ALCON - BELGIUM / S.A. ALCON-COUVREUR N.V. NA 08E19B

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention BSS