BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROVISC

    MDR report key: 2100622 · Received May 13, 2011

    Report

    Report Number
    3002037047-2011-00025
    Event Type
    Malfunction
    Date Received
    May 13, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 13, 2011
    Manufacturer
    ALCON-BELGIUM/S.A. ALCON-COUVREUR N.V.
    Product Code
    LZP
    PMA / PMN Number
    P890047
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED. LOT HISTORY WAS REVIEWED AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED SO FAR FOR THIS LOT. A VISUAL INSPECTION OF THE BATCH RECORD WAS COMPLETED AND ALL SYRINGES ARE VISUALLY INSPECTED, ITEMS WITH INCOMPLETELY ASSEMBLED LUER LOCK ADAPTERS ARE REMOVED. NO LOOSE LUER LOCK ADAPTORS WERE FOUND FOR THIS BATCH. A FUNCTIONALITY TEST WAS PERFORMED ON RETENTION SAMPLES, RESULTS WERE OK. THE COMPLAINT SAMPLE WAS INVESTIGATED BY THE SUPPLIER QA DEPT AND THE ANALYSIS SHOWED THAT THE LUER LOCK ADAPTOR WAS DETACHED FROM THE SYRINGE. THE SAMPLE WAS SENT TO THE SUPPLIER FOR FURTHER ANALYSIS. IF AN ADD'L REPORTABLE INFO BECOMES AVAILABLE, A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56. INVESTIGATION OF THE COMPLAINT SAMPLES WAS PERFORMED BY THE MFR OF THE SYRINGES. RESULTS OF THIS INVESTIGATION SHOWED THAT THERE WERE NO DEVIATIONS RELATED TO THE INDIVIDUAL COMPONENTS. DIMENSIONS AND FUNCTIONALITY WERE TESTED AND THE GLASS BARREL AS WELL AS THE PLASTIC LLA CONFORMED. AFTER REASSEMBLY OF THE LLA, IT WAS NOT POSSIBLE TO SIMULATE DETACHMENT ON THE COMPLAINT SAMPLES ACCORDING TO THE DIRECTIONS FOR USE (DFU). HOWEVER, WHEN THESE INSTRUCTIONS FOR USE WERE NOT FOLLOWED OR IF OTHER NON-ALCON COMPONENTS WERE USED A MALFUNCTIONING OF THE DEVICE COULD BE SIMULATED. ROOT CAUSE INDICATES INCORRECT HANDLING BY THE CUSTOMER, NOT FOLLOWING THE INSTRUCTIONS OF THE DFU. (B)(4).

    Description of Event or Problem · 1

    A OPHTHALMIC SURGEON REPORTED THE CANNULA ROCK WAS DETACHED. HE STATED THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROVISC AID, SURGICAL, VISCOELASTIC LZP ALCON-BELGIUM/S.A. ALCON-COUVREUR N.V. NA 10K08G

    Patients

    Seq Age Sex Outcome Treatment
    1