BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IOLMASTER 700

    MDR report key: 5767743 · Received July 3, 2016

    Report

    Report Number
    9615030-2016-00008
    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 THE CUSTOMER'S WORKFLOW AND THE PATIENT MEASUREMENT AND CALCULATION PRINTOUTS. THE CAS DETERMINED THAT THE HCP ENTERED LENS CONSTANTS FOR THE ALCON SN6AT, WHICH WERE DIFFERENT TO THE RESPECTIVE LENS CONSTANTS LISTED ON THE MANUFACTURER RECOMMENDED (B)(4) WEBPAGE. THE SOURCE OF THE LENS CONSTANTS USED IS UNKNOWN. THE CAS DEMONSTRATED THAT THE LENS CONSTANTS FROM THE (B)(4) DATABASE 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 TWO 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 ALCON SN6AT INTRAOCULAR LENS (IOL) IMPLANTATION DIFFERED BY 2 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
    421748 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