BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROVISC OPHTHALMIC VISCOSURGICAL DEVICE

    MDR report key: 4943113 · Received July 27, 2015

    Report

    Report Number
    3002037047-2015-00546
    Event Type
    Malfunction
    Date Received
    July 27, 2015
    Report Date
    October 23, 2015
    Manufacturer
    ALCON - COUVREUR N.V./ALCON - BELGIUM
    Product Code
    LZP
    PMA / PMN Number
    P890047
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FOR THE REPORTED LOT NUMBER. NO REMARKS WERE NOTED IN THE BATCH RECORD FILLING AND ASSEMBLY. THE POSITION OF THE SLEEVE CAP IS INSPECTED BY AN AUTOMATED SYSTEM. THE FUNCTIONALITY OF THIS DETECTION SYSTEM WAS TESTED AND WAS SATISFACTORY. AFTER ASSEMBLY, THE SYRINGES ARE 100% VISUALLY INSPECTED AND ITEMS WITH INCORRECTLY PLACED SLEEVE CAPS OR DEFECTIVE SLEEVES ARE REJECTED. ONE VISCOELASTIC SYRINGE SAMPLE WAS RECEIVED BY MANUFACTURING WHICH APPEARED UNUSED BASED ON THE FILL VOLUME. INVESTIGATION OF THE COMPLAINT SAMPLE REVEALED THAT ONE OF THE FIXATION HOOKS OF THE SLEEVE CAP WAS BROKEN. THE BROKEN FIXATION HOOK WAS IN FRONT OF THE INJECTION POINT. THIS SLEEVE HOOK CAN BREAK DURING THE CAPPING WHEREBY A LARGE OUTWARD FORCE IS EXERTED ON THESE BRACKETS. A QUALITY REMARK (B)(4) HAS BEEN MADE TO FOLLOW UP WITH THE SUPPLIER. FEEDBACK OF THIS INTERNAL, ASSEMBLY RELATED COMPLAINT WILL BE TAKEN UP IN THE NEXT TRAINING OF THE PACKAGING OPERATORS TO INCREASE THE AWARENESS. (B)(4).

    Additional Manufacturer Narrative · 1

    A SAMPLE HAS BEEN RECEIVED BY MANUFACTURING THAT HAS NOT YET BEEN EVALUATED. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A DOCTOR REPORTED THAT FOREIGN MATERIAL LIKE PLASTIC WAS NOTED INSIDE OF THE VISCOELASTIC SOLUTION PRIOR TO SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487867 PROVISC OPHTHALMIC VISCOSURGICAL DEVICE AID, SURGICAL, VISCOELASTIC LZP ALCON - COUVREUR N.V./ALCON - BELGIUM NA 14K20L

    Patients

    Seq Age Sex Outcome Treatment
    1 Other