BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IOLMASTER 700

    MDR report key: 5767742 · Received July 3, 2016

    Report

    Report Number
    9615030-2016-00007
    Event Type
    Injury
    Date Received
    July 3, 2016
    Report Date
    June 3, 2016
    Manufacturer
    CARL ZEISS MEDITEC AG (JENA)
    Product Code
    HJO
    PMA / PMN Number
    K143275
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NARRATIVE: A ZEISS CLINICAL APPLICATION SPECIALIST (CAS) EVALUATED ON-SITE THE CUSTOMER'S WORKFLOW AND THE PATIENT MEASUREMENT AND CALCULATION PRINTOUTS. THE CAS DETERMINED THAT THE HCP ENTERED THE SRK-T LENS CONSTANT INSTEAD OF THE MANUFACTURER A CONSTANT FOR CALCULATING THE FORMULA SPECIFIC LENS CONSTANTS, WHICH THEN LED TO THE INCORRECT IOL POWER CALCULATION. THE CAS DEMONSTRATED THAT THE CORRECT MANUFACTURER A CONSTANT VALUE WOULD HAVE LED TO THE DESIRED RESULT AND RETRAINED THE HCP. HOW TO USE THE IOLMASTER 700 FOR IOL CALCULATION AND HOW TO USE THE LENS CONSTANTS IS DESCRIBED IN THE USER MANUAL. FOR INSTANCE ON PAGE 53 OF USER MANUAL 00000-1932-169 IT IS STATED "THE IOL CALCULATION IS VALID ONLY IF THE BIOMETRIC MEASUREMENT WAS CORRECT, AN APPROPRIATE IOL CALCULATION FORMULA WAS SELECTED AND THE IOL CONSTANTS WERE OPTIMIZED FOR THE SPECIFIC APPLICATION." A WARNING MESSAGE IS GIVEN ON PAGE 76 WITH "CONSTANTS SUBJECT TO THE LENS TYPE MUST BE DEFINED AND ENTERED PRIOR TO USING THE IOLMASTER 700." AND WITH "THE CONSTANTS SHOULD THUS BE SUBJECTED TO REGULAR REVIEW AND REFINEMENT." THE DEVICE MANUFACTURE DATE FOR IOLM 700 S/N (B)(4) IS 12/2015 AND FOR IOLM 700 S/N (B)(4) IT IS 05/2016. THE MANUFACTURER RECEIVED DIFFERENT INFORMATION FROM THE CUSTOMER, WHICH INSTRUMENT WAS INVOLVED IN THE INCIDENT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THIS IS CASE ONE OF TWO REPORTED CASES FROM SAME CUSTOMER SITE. THE HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT THE POST REFRACTIVE OUTCOME AFTER A CATARACT SURGERY USING AN AMO TECHNIS INTRAOCULAR LENS (IOL) IMPLANTATION DIFFERED BY 2.5 DIOPTERS FROM THE TARGET REFRACTION. IT WAS FURTHER REPORTED THAT LASIK SURGERY TO IMPROVE THE VISUAL ACUITY IS PLANNED. NO FURTHER INFORMATION REGARDING THE PATIENT AND INCIDENT COULD BE OBTAINED. THE HCP USED THE IOLMASTER 700 FOR THE BIOMETRY MEASUREMENTS AND IOL CALCULATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421747 IOLMASTER 700 BIOMICROSCOPE, SLIT-LAMP, AC-POWERED, PRODUCT CODE: HJO HJO CARL ZEISS MEDITEC AG (JENA) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other