BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPMI 6 S FC ON S3-B

    MDR report key: 468277 · Received June 26, 2003

    Report

    Report Number
    2431026-2003-00002
    Event Type
    Injury
    Date Received
    June 26, 2003
    Date of Event
    May 28, 2003
    Report Date
    June 26, 2003
    Manufacturer
    CARL ZEISS, INC.
    Product Code
    EPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING CATARACT REMOVAL PROCEDURE PATIENT ALLEGEDLY RECEIVED A RETINAL PHOTIC INJURY. FILTER WAS IN PLACE. LENGTH OF PROCEDURE REPORTED AT 41 MINUTES. FACILITY ALLEGES POST-OPERATIVE EXAMINATION INDICATES RETINAL INJURY TO LEFT, IN THE MACULA AND PARAMACULA; METAMORPHOPSIA CENTRALLY ON AMSLER GRID AND RELATIVE SCOTOMA SUPERIOR TEMPORAL TO FIXATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPMI 6 S FC ON S3-B SURGICAL MICROSCOPE EPT CARL ZEISS, INC. SERIAL NUMBER 149674 *

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other