BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROVISC OPHTHALMIC VISCOSURGICAL DEVICE

    MDR report key: 5022327 · Received August 21, 2015

    Report

    Report Number
    3002037047-2015-00549
    Event Type
    Injury
    Date Received
    August 21, 2015
    Report Date
    November 29, 2015
    Manufacturer
    ALCON - COUVREUR N.V./ALCON - BELGIUM
    Product Code
    LZP
    PMA / PMN Number
    P890047
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO LOT NUMBER INFORMATION WAS AVAILABLE, A LOT SPECIFIC INVESTIGATION RELATED TO THIS COMPLAINT COULD NOT BE PERFORMED. NO ACTUAL DEVICE SAMPLE WAS RECEIVED HOWEVER, AN INCOMPLETELY CLOSED CONTAINER CONTAINING LIQUID WAS RECEIVED BY MANUFACTURING. MICROSCOPICAL INVESTIGATION OF THE RECEIVED LIQUID REVEALED A SMALL FOREIGN PARTICLE OF UNKNOWN ORIGINS. THE FOREIGN PARTICLE WAS FURTHER EVALUATED BY THE PARTICLE LAB FOR IDENTIFICATION. MICROSCOPIC EXAMINATION NOTED A YELLOW/BROWN PLASTIC APPEARING PARTICLE THAT WAS APPROXIMATELY 75UM IN SIZE. THE PARTICLE WAS ISOLATED AND ANALYZED USING MICROSCOPIC FOURIER TRANSFORM INFRARED SPECTROSCOPY (MICRO FT-IR). COMPARISON OF THE MATERIAL'S GENERATED IR SPECTRA TO A LIBRARY OF SPECTRA FINDS THE BEST MATCH TO BE MICROTIP SUPPRESSOR INSERT MATERIAL. BASED ON THIS EVALUATION, THE PARTICLE POTENTIALLY ORIGINATED FROM ONE OF THE TIPS USED DURING SURGERY. THE ROOT CAUSE IS THEREFORE ATTRIBUTED TO MATERIAL THAT ORIGINATED FROM A MICROTIP SUPPRESSOR INSERT. (B)(4).

    Additional Manufacturer Narrative · 1

    NO LOT NUMBER INFORMATION IS AVAILABLE. A SAMPLE IS AVAILABLE THAT HAS NOT YET BEEN RECEIVED BY MANUFACTURING FOR EVALUATION. 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 AFTER COMPLETION OF A PROCEDURE IN WHICH VISCOELASTIC PRODUCT HAD BEEN USED, A PIECE OF FOREIGN MATERIAL DEBRIS WAS NOTED TO REMAIN INSIDE OF THE PATIENT'S EYE. AN ADDITIONAL PROCEDURE IS SCHEDULED IN ORDER TO REMOVE THE DEBRIS FROM THE PATIENT'S EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT THERE WAS NO SYMPTOM CAUSED TO THE PATIENT FROM THE FOREIGN MATERIAL OBSERVED INSIDE OF THE EYE. ADDITIONAL INFORMATION RECEIVED NOW CONFIRMS THAT THE DEBRIS WAS SUCCESSFULLY REMOVED FROM THE PATIENT'S EYE DURING AN ADDITIONAL PROCEDURE. THE SURGEON NOW SUSPECTS THAT THE DEBRIS IS FIBROUS IN NATURE AND QUITE UNLIKELY TO BE ASSOCIATED WITH THE VISCOELASTIC PRODUCT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554289 PROVISC OPHTHALMIC VISCOSURGICAL DEVICE AID, SURGICAL, VISCOELASTIC LZP ALCON - COUVREUR N.V./ALCON - BELGIUM NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other