BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMETER LENSTAR LS 900

    MDR report key: 2596801 · Received May 24, 2012

    Report

    Report Number
    1000176188-2012-00002
    Event Type
    Injury
    Date Received
    May 24, 2012
    Date of Event
    April 10, 2012
    Report Date
    May 24, 2012
    Manufacturer
    HAAG-STREIT AG
    Product Code
    HJO
    PMA / PMN Number
    K082891
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BIOMETER LENSTAR LS 900 DID NOT CONTRIBUTE TO THE PROBLEM. FURTHER INFO TO D10 AND H3 - PT DATA, MEASUREMENT DATA AND IOL DATA WERE AVAILABLE FOR INVESTIGATION. DEVICE MFR DATE REFERS TO THE EYE SUITE SOFTWARE. THE WRONG MEASUREMENT RESULT WAS CAUSED BY A COMBINATION OF ANATOMICAL DETAILS (VERY THICK LENS) AND VERY UNUSUAL SIGNAL FEEDBACK (VERY STRONG SIGNAL FROM THE POSTERIOR LENS CAPSULE). THIS LED TO A WRONG MEASUREMENT RESULT ON THE RIGHT EYE. EYESUITE PROVIDED THE USER WITH TWO WARNINGS: THE 1ST WARNING WAS THAT THE LEFT AND THE RIGHT EYE OF THE PT SHOW SIGNIFICANT DIFFERENCE IN THE AXIAL LENGTH MEASUREMENT. THE 2ND WARNING WAS THAT THE RESULT FOR THE AXIAL LENGTH MEASUREMENT IN THE RIGHT EYE SHOWS AN EXTREMELY HIGH STANDARD DEVIATION (0.095MM). WHENEVER EYESUITE PROVIDES THE USER WITH WARNINGS THAT IT IS MANDATORY TO PERFORM PLAUSIBILITY CHECKS OF THE MEASUREMENTS BY LOOKING AT THE RAW MEASUREMENT DATA AS DETAILED IN THE LENSTAR LS 900 INSTRUCTIONS FOR USE. ADDITIONALLY, THE OVERALL EYE-STATUS MUST BE CONSIDERED IN THIS PLAUSIBILITY CHECK. IN THE PARTICULAR CASE IT SEEMS THAT THIS PLAUSIBILITY CHECK WAS NOT PERFORMED. BASED ON THE ANALYSIS HAAG-STREIT (B)(4) CONCLUDED THAT BOTH INSTRUMENT AND CORRESPONDING SOFTWARE FUNCTIONED ACCORDING SPECS AND INTENDED USE. HAAG-STREIT USA INFORMED THE USER ON (B)(4) 2012, ABOUT THE RESULTS OF THE INVESTIGATION, RECOMMENDED THAT HE FOLLOWS THE INSTRUCTIONS FOR USE IN THE FUTURE AND OFFERED RE-TRAINING FOR THE USER AND HIS STAFF.

    Description of Event or Problem · 1

    BOTH BIOMETRY AND SURGERY WERE PERFORMED ON THE SAME DAY. ON THE FOLLOWING DAY, IT WAS REALIZED THAT THE PT HAD 20/20 NEAR VISION AND 20/250 DISTANCE VISION. THE TARGET OF THE SURGERY WAS GOOD DISTANCE VISION. DISTANCE VISION OF 20/25 WAS ACHIEVED WITH A SPHERICAL CORRECTION OF -3.5 D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMETER LENSTAR LS 900 LENSTAR HJO HAAG-STREIT AG LS 900

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention