BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSTAR LS900

    MDR report key: 6181227 · Received December 16, 2016

    Report

    Report Number
    1000176188-2016-00002
    Event Type
    Injury
    Date Received
    December 16, 2016
    Date of Event
    November 16, 2016
    Report Date
    December 16, 2016
    Manufacturer
    HAAG-STREIT AG
    Product Code
    HJO
    PMA / PMN Number
    K082891
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A NEW LENSTAR LS900 S/N: (B)(4) AND COMPUTER WAS INSTALLED BY CLINICAL APPLICATION SPECIALISTS FROM HAAG-STREIT USA. HAAG-STREIT USA IS CURRENTLY AWAITING FOR FILES TO SEND TO HAAG-STREIT (B)(4) FOR FURTHER EVALUATION.

    Description of Event or Problem · 1

    THE STORAGE OF THE PATIENT DATA WAS STORED UNDER THE WRONG PATIENT. A PATIENT WAS SCANNED WITH THE LENSTAR LS900, S/N: (B)(4) AROUND 4:15 PM ON (B)(6) 2016 AND THE SECOND PATIENT WAS SCANNED AROUND 4:23 PM ON THIS SAME DAY. THE BIOMETRY READINGS FOR THE FIRST PATIENT WERE STORED IN EYE SUITE UNDER BOTH PATIENT NAMES. THE CLINICAL APPLICATION SPECIALIST VERIFIED WITH THE IOL PRINTOUTS THAT THE CALCULATIONS WERE EXACTLY THE SAME, BUT THE PATIENT DEMOGRAPHICS AT THE TOP WERE DIFFERENT. THIS CAUSED THE IOL CALCULATIONS FOR THE SECOND PATIENT TO BE INACCURATE AND THEY HAD THE INCORRECT LENSES INSTALLED DURING THEIR SURGERY CAUSING THE NEED FOR A SECOND SURGERY IN ORDER TO CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833095 LENSTAR LS900 LENSTAR, MODEL LS900 HJO HAAG-STREIT AG LS900 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention