BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCEPS

    MDR report key: 522338 · Received February 6, 2004

    Report

    Report Number
    1610287-2004-00002
    Event Type
    Malfunction
    Date Received
    February 6, 2004
    Report Date
    January 9, 2004
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    HNR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTER NOTED FORCEPS MAY HAVE SCRATCHED IOL IN THREE CASES; ONE LENS WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORCEPS FORCEPS HNR ALCON LABORATORIES, INC. GR 560.01 F45185

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO