BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE

    MDR report key: 5027869 · Received August 25, 2015

    Report

    Report Number
    3002037047-2015-00551
    Event Type
    Injury
    Date Received
    August 25, 2015
    Date of Event
    July 24, 2015
    Report Date
    October 1, 2015
    Manufacturer
    ALCON - COUVREUR N.V./ALCON - BELGIUM
    Product Code
    LZP
    PMA / PMN Number
    P840064
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILLED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: MANUFACTURING ANALYSIS REVIEW WAS PERFORMED. ALL BATCHES WERE RELEASED ACCORDING TO THE REQUIRED SPECIFICATIONS; ALL TESTING RESULTS WERE WITHIN SPECIFICATION FOR THIS BATCH. THE RETURNED SAMPLES WERE RETESTED: ALL RESULTS WERE CONFORM TO THE SPECIFICATIONS FOR THE TESTED PARAMETERS. THE ROOT CAUSE REMAINS INCONCLUSIVE, THE PRODUCT MET SPECIFICATIONS.

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED THROUGH THE REGULATORY AUTHORITY IN (B)(6) A CASE OF CORNEAL OPACITY FOLLOWING THE USE OF A VISCOELASTIC DURING A CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE. THIS IS ONE OF TWO REPORTS BEING FILED FOR THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560881 VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE AID, SURGICAL, VISCOELASTIC LZP ALCON - COUVREUR N.V./ALCON - BELGIUM NA 15C25E

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other