BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISCOVISC

    MDR report key: 2100628 · Received May 13, 2011

    Report

    Report Number
    3002037047-2011-00026
    Event Type
    Malfunction
    Date Received
    May 13, 2011
    Date of Event
    January 1, 2011
    Report Date
    April 14, 2011
    Manufacturer
    ALCON-BELGIUM/S.A. ALCON-COUVREUR N.V.
    Product Code
    LZP
    PMA / PMN Number
    P840064
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RECEIVED FOR EVAL. AN EMPTY CARTON WAS RECEIVED AT WHICH TIME NO FURTHER INVESTIGATION WAS POSSIBLE. LOT HISTORY WAS REVIEWED AND NO SIMILAR COMPLAINTS HAVE BEEN REPORTED FOR THIS LOT. A RETENTION SAMPLE WAS TESTED AND ALL RESULTS CONFORMED TO THE SPECS FOR THE TESTED PARAMETERS. NO FOREIGN MATERIAL WAS OBSERVED IN THE RETENTION SAMPLE. THERE WERE NO REMARKS IN BATCH RECORD FILLING. ALL SYRINGES WERE VISUALLY INSPECTED FOR FOREIGN MATERIAL BY QUALIFIED OPERATORS AND ITEMS WITH FOREIGN PARTICLES WERE REJECTED. NO ROOT CAUSE COULD BE IDENTIFIED. ADD'L INFO WAS REQUESTED ON 04/27/2011 AND 05/06/2011. (B)(4).

    Description of Event or Problem · 1

    AN OPHTHALMIC SURGEON REPORTED THERE WAS A BLACK FOREIGN PARTICLE IN THIS PRODUCT THAT GOT INTO THE PT'S EYE DURING SURGERY. ON (B)(6) 2011, ADD'L INFO WAS RECEIVED STATING THE PARTICLE WAS COMPLETELY ASPIRATED FROM THE PT'S EYE WITHOUT PT HARM.

    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 10H26F

    Patients

    Seq Age Sex Outcome Treatment
    1