BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROVISC OPHTHALMIC VISCOSURGICAL DEVICE

    MDR report key: 15697223 · Received October 29, 2022

    Report

    Report Number
    3002037047-2022-00063
    Event Type
    Injury
    Date Received
    October 29, 2022
    Date of Event
    October 1, 2022
    Report Date
    February 21, 2023
    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
    RO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. CITATION: DC. INTRAOCULAR PRESSURE AFTER CATARACT SURGERY USING PROVASC, VISCOAT EITHER SEPARATELY OR IN COMBINATION, OFTALMOLOGIA; 2008, 52(3):91-7. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    NO LOT CODE OR SAMPLE PROVIDED. NO FURTHER EVALUATION OR ROOT CAUSE ANALYSIS CAN BE CONDUCTED AT THIS TIME. NO ROOT CAUSE COULD BE DETERMINED AS NO SAMPLE OR LOT CODE WAS PROVIDED FOR ANALYSIS. NO ACTION IS WARRANTED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED A LITERATURE STUDY TO COMPARE THE INTRA-OCULAR PRESSURE (IOP) POST-OPERATIVELY AFTER SMALL-INCISION CATARACT SURGERY USING DIFFERENT VISCOELASTIC PRODUCTS. THE PATIENTS WERE RANDOMIZED TO RECEIVE EITHER TWO DIFFERENT VISCOELASTIC PRODUCTS OR COMBINATION OF BOTH OF THEM. THERE WERE NO STATISTICALLY SIGNIFICANT DIFFERENCES BETWEEN THE STUDY GROUPS CONCERNING THE IOP VALUES MEASURED AT DIFFERENT INTERVALS POST-OPERATIVELY. THERE WERE SIX PATIENTS THAT HAD INCREASED IOP AND REQUIRED ANTI GLAUCOMATOUS EYE DROPS. BUT THE EXACT PRODUCT TO THE SIX PATIENTS WAS NOT PROVIDED, RESPECTIVELY. ADDITIONAL INFORMATION COULD NOT BE OBTAINED AS THE REPORTER IS UNWILLING TO FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2881919 PROVISC OPHTHALMIC VISCOSURGICAL DEVICE AID, SURGICAL, VISCOELASTIC LZP ALCON - COUVREUR N.V./ALCON - BELGIUM NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention