BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPMI 6 SFR XY ON S3 FLOORSTAND

    MDR report key: 501552 · Received December 17, 2003

    Report

    Report Number
    2431026-2003-00004
    Event Type
    Injury
    Date Received
    December 17, 2003
    Date of Event
    November 18, 2003
    Report Date
    December 16, 2003
    Manufacturer
    CARL ZEISS
    Product Code
    EPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING PROCEDURE TO CORRECT DECENTERED IOL, VITRECTOMY AND CHANGING POSTERIOR CHAMBER LENS FOR ANTERIOR CHAMBER LENS IN OS, PT ALLEGEDLY RECEIVED RETINAL PHOTIC INJURY TO MACULA IN CENTRAL FIELD OF VISION. TOTAL TIME OF PROCEDURE REPORTED AS 1 HOUR 10 MINUTES. FACILITY REPORTS THAT POST-OPERATIVE ACUITY IS 20/200.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPMI 6 SFR XY ON S3 FLOORSTAND SURGICAL MICROSCOPE EPT CARL ZEISS 6 SFR *

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other