BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUOVISC VISCOELASTIC SYSTEM

    MDR report key: 8703300 · Received June 17, 2019

    Report

    Report Number
    3002037047-2019-00006
    Event Type
    Injury
    Date Received
    June 17, 2019
    Date of Event
    April 3, 2019
    Report Date
    December 4, 2019
    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
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN PROVIDED IN H.6. AND H.10. IN THE PREVIOUS TWELVE MONTHS THERE WERE NO SIMILAR COMPLAINTS. NO CUSTOMER SAMPLE WAS RETURNED. A REVIEW OF THE BATCH RECORD AND RAW MATERIALS FOUND NO GLUTEN. ROOT CAUSE CANNOT BE DETERMINED BASED ON CURRENT AVAILABLE DATA AND NO SAMPLE RECEIVED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN PROVIDED IN A.1., B.3., B.5. AND H.6. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE PATIENT PRESENTED TO POST OPERATIVE APPOINTMENT THE NEXT DAY WITH EDEMA AND CONJUNCTIVAL HEMORRHAGE. THE ANTERIOR CHAMBER WAS RINSED AND TOPICAL TREATMENT WAS REQUIRED, THERE WAS A TEMPORARY CHANGE IN THE PATIENT'S VISUAL ACUITY. THE PATIENT WAS GIVEN A POST OPERATIVE PREVENTATIVE TREATMENT OF STEROID AND ANTIBIOTIC FOR FIFTEEN DAYS.

    Additional Manufacturer Narrative · 1

    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. (B)(4).

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED A PATIENT EXPERIENCED AN IMMUNE RESPONSE FOLLOWING A CATARACT EXTRACTION PROCEDURE WITH INTRAOCULAR LENS IMPLANT. THE PATIENT WAS TREATED WITH CORTISONE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496479 DUOVISC VISCOELASTIC SYSTEM AID, SURGICAL, VISCOELASTIC LZP ALCON - COUVREUR N.V./ALCON - BELGIUM NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention