BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IOLMASTER 700

    MDR report key: 11987127 · Received June 11, 2021

    Report

    Report Number
    9615030-2021-00010
    Event Type
    Injury
    Date Received
    June 11, 2021
    Report Date
    May 14, 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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REQUEST FOR DATA FOR THE AFFECTED PATIENT WAS REQUESTED FROM THE HCP. HOWEVER, THE HCP DID NOT PROVIDE THIS INFORMATION. THEREFORE, FURTHER EVALUATION IS NOT POSSIBLE. DESCRIPTION OF CHANGES: FIELD G1-2: UPDATED TO "CONTACT OFFICE" FIELD G7: UPDATED TO "FOLLOW-UP #: 1" FIELD H2: UPDATED TO "ADDITIONAL INFORMATION" AND "DEVICE EVALUATION" FIELD H3: UPDATED TO "YES". ADDED "EVALUATION SUMMARY ATTACHED" FIELD H6: UPDATED INVESTIGATION FINDINGS CODE TO "4310". UPDATED INVESTIGATION CONCLUSIONS CODE TO "4310". FIELD H10: ADDED MANUFACTURER'S NARRATIVE. ADDED DESCRIPTION OF CHANGES

    Additional Manufacturer Narrative · 1

    A REQUEST FOR DATA FOR THE AFFECTED PATIENT HAS BEEN REQUESTED FROM THE HCP FOR FURTHER EVALUATION.

    Description of Event or Problem · 1

    A HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT THERE HAS BEEN AN INCORRECT SURGICAL RESULT AFTER USING THE IOLMASTER 700 FOR THE BIOMETRY MEASUREMENTS AND LENS POWER CALCULATIONS. THE HCP REPORTED THAT A LENS EXCHANGE WAS PERFORMED TO CORRECT THEPATIENT'S VISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877982 IOLMASTER 700 BIOMICROSCOPE, SLIT-LAMP, AC-POWERED HJO CARL ZEISS MEDITEC AG (JENA) 700 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention