BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISCOVISC

    MDR report key: 1202837 · Received October 17, 2008

    Report

    Report Number
    3002037047-2008-00084
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    August 14, 2008
    Report Date
    September 19, 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
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT HAS NOT BEEN RECEIVED FOR EVALUATION. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER HAS NOT PROVIDED A LOT NUMBER, OR ANY ID TRACEABLE TO THE MFG DOCUMENTATION. ADD'L INFO WAS REQUESTED ON 09/22/2008 BY PHONE, FAX AND MAIL. A COMPLETED STUDY FORM WAS RECEIVED; A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (OTHER(FOR USE WHEN AN APPROPRIATE DEVICE CODE CANNOT BE IDENTIFIED). THIS REPORT WAS MAILED TO FDA ON: 10/17/2008.

    Description of Event or Problem · 1

    A STUDY INVESTIGATOR REPORTED A PT'S INTRAOCULAR PRESSURE SPIKED FOLLOWING USE OF THIS PRODUCT IN A STUDY. THE IOP RISE OCCURRED ONE DAY FOLLOWING SURGERY. PT WAS TREATED WITH A PARS PLANA TAP TO RELEASE AQUEOUS THROUGH THE PARACENTESIS. THE EVENT RESOLVED. ADD'L INFO WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISCOVISC AID, SURGICAL, VISCOELASTIC LZP ALCON-BELGIUM/S.A. ALCON-COUVREUR N.V NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention