BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROVISC OPHTHALMIC VISCOSURGICAL DEVICE

    MDR report key: 6100697 · Received November 14, 2016

    Report

    Report Number
    3002037047-2016-00182
    Event Type
    Injury
    Date Received
    November 14, 2016
    Report Date
    November 14, 2016
    Manufacturer
    ALCON - COUVREUR N.V./ALCON - BELGIUM
    Product Code
    LZP
    PMA / PMN Number
    P890047
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE OR LOT NUMBER INFORMATION HAS BEEN RECEIVED BY MANUFACTURING FOR EVALUATION PER THIS LITERATURE ARTICLE. 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. THIS IS THE FIRST OF TWO REPORTS FROM THIS LITERATURE ARTICLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    IN A LITERATURE REPORT IT WAS INDICATED THAT VISCOELASTIC PRODUCTS WERE USED DURING AN INTRAOCULAR LENS (IOL) INSERTION WHEN AN AUDIBLE CRUNCHING SOUND WAS HEARD. WHITE GRANULAR MATERIAL WAS NOTED ON THE LENS AND IN THE ANTERIOR CHAMBER. THE MATERIAL WAS PARTIALLY REMOVED WITH IRRIGATION. THE LENS WAS CUT IN HALF AND REMOVED FROM THE EYE. THE REMAINING WHITE MATERIAL WAS RETRIEVED THROUGH VIGOROUS ASPIRATION AND IRRIGATION. SOME OF THE MATERIAL COULD NOT BE COMPLETELY REMOVED FROM THE WOUND. ANOTHER LENS WAS THEN IMPLANTED SUCCESSFULLY. THE WOUND WAS HYDRATED WITH BALANCED SALINE SOLUTION, SUBCONJUNCTIVAL ANTIBIOTICS WERE INJECTED AND SODIUM CHLORIDE OINTMENT WAS PLACED IN THE EYE. THE PATIENT RECEIVED AN ANTIBIOTIC INJECTION WAS ALSO GIVEN ORAL ANTIBIOTICS FOR 10 DAYS POSTOPERATIVELY. THE PATIENT DEVELOPED CORNEAL EDEMA POSTOPERATIVELY AT ONE WEEK THAT RESOLVED AT ONE MONTH. HALF OF THE LENS WAS SENT FOR CULTURE AND THE OTHER HALF WAS SENT FOR FURTHER ANALYSIS. OF THE PART OF THE LENS SENT FOR CULTURE, THE RESULT WAS THAT THE LENS AND CARTRIDGE GREW BACILLUS SPECIES. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749415 PROVISC OPHTHALMIC VISCOSURGICAL DEVICE AID, SURGICAL, VISCOELASTIC LZP ALCON - COUVREUR N.V./ALCON - BELGIUM NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other BSS| CEFAZOLIN| CLINDAMYCIN| LEVOFLOXACIN (ORAL AND INJECTION)| MURO 128| VANNAS SCISSORS