BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IOLMASTER 700

    MDR report key: 11652278 · Received April 12, 2021

    Report

    Report Number
    9615030-2021-00008
    Event Type
    Injury
    Date Received
    April 12, 2021
    Date of Event
    March 4, 2021
    Report Date
    April 2, 2021
    Manufacturer
    CARL ZEISS MEDITEC AG (JENA)
    Product Code
    HJO
    PMA / PMN Number
    K143275
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER EVALUATED THE PROVIDED PATIENT DATA. BASED ON THIS EVALUATION THE MANUFACTURER CONCLUDED THAT THERE IS SOME TYPE OF ERROR MEASUREMENT THAT OCCURRED WITH THE OS KERATOMETER (KER) VALUES. THIS COULD BE CONTACT LENSES BEFORE MEASUREMENT, EYE DROPS BEFORE KER MEASUREMENT OR PATHOLOGY ON OS KER. THE DEVICE WORKED ACCORDING TO SPECIFICATION. DESCRIPTIONS OF CHANGES: FIELD G7: UPDATED TO "FOLLOW-UP #: 1" FIELD H6: UPDATED CONCLUSION CODE TO "4315" FIELD H10: ADDED MANUFACTURER NARRATIVE. ADDED DESCRIPTIONS OF CHANGES.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER RECEIVED ONE OF THE PATIENT'S DATA PROVIDED BY THE HCP AND IT IS CURRENTLY UNDER REVIEW. A REQUEST FOR ADDITIONAL DATA FOR OTHER PATIENTS WERE REQUESTED FROM THE HCP.

    Description of Event or Problem · 1

    A HEALTH CARE PROFESSIONAL (HCP) REPORTED ON MARCH 2, 2021 THAT THERE HAS BEEN AN INCORRECT SURGICAL RESULT AFTER USING THE IOLMASTER 700 FOR THE BIOMETRY MEASUREMENTS AND LENS POWER CALCULATIONS. THE HCP REPORTED ON APRIL 2, 2021 THAT A LENS EXCHANGE HAD BEEN PERFORMED ON (B)(6) 2021 TO CORRECT THE PATIENT'S VISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549169 IOLMASTER 700 BIOMICROSCOPE, SLIT-LAMP, AC-POWERED HJO CARL ZEISS MEDITEC AG (JENA) 700 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention