BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EYE LASER ZEISS IOL 700

    MDR report key: 19049538 · Received April 4, 2024

    Report

    Report Number
    MW5153552
    Event Type
    Injury
    Date Received
    April 4, 2024
    Date of Event
    January 22, 2024
    Report Date
    April 2, 2024
    Manufacturer
    CARL ZEISS MEDITEC AG (OBERKOCHEN)
    Product Code
    HJO
    UDI-DI
    04049471092080
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE ZEISS LASERS (ZEISS IOL 700) WERE CALIBRATED PER THE INTERNAL TEST EYE PHANTOM AND DEEMED CALIBRATED. IN FACT THE CALIBRATION WAS .06 DIOPTERS (.85MM) OUT OF SPECIFICATION AND LED TO 4 PATIENTS HAVING A LASER EYE CORRECTION INTERVENTION THAT DID NOT HAVE THE EXPECTED OUTCOME. PATIENTS WERE IDENTIFIED AFTER THEIR 1 WEEK POST SURGERY CONSULT. PATIENTS WERE TESTED AND ALL FOUND TO HAVE THE SAME OUT OF SPECIFICATION OUTCOME. COMMON OFFENDER WAS THE LASER AND IT WAS PULLED FROM SERVICE. ON INVESTIGATION THE LASER WAS NOT CALIBRATED ACCURATELY, AND COULD NOT HAVE BEEN, AND WAS CONSEQUENTLY SUBMITTED FOR SERVICE BY THE MANUFACTURER. ZEISS HAS HAD THE LASER TURNED OVER TO THEM. REFERENCE REPORTS: MW5153549, MW5153550, MW5153551.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539828 EYE LASER ZEISS IOL 700 BIOMICROSCOPE, SLIT-LAMP, AC-POWERED HJO CARL ZEISS MEDITEC AG (OBERKOCHEN) 700 04049471092080

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Prefer Not To Disclose Required Intervention| S| O