BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERION REFERENCE UNIT

    MDR report key: 4871783 · Received June 26, 2015

    Report

    Report Number
    3010300699-2015-00505
    Event Type
    Injury
    Date Received
    June 26, 2015
    Date of Event
    February 18, 2015
    Report Date
    July 31, 2015
    Manufacturer
    WAVELIGHT GMBH (AGPS)
    Product Code
    HJB
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS, IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION, AT THIS TIME THE CUSTOMER HAS INDICATED NO ADDITIONAL INFORMATION WILL BE PROVIDED. (B)(4).

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: NO TECHNICAL ROOT CAUSE COULD BE DETERMINED. CONTRIBUTING FACTORS FOR REPORTED ISSUE COULD BE ATTRIBUTED TO A POOR DIAGNOSTIC IMAGE, USE OF A NON OPTIMIZED FORMULA DURING PLANNING, OR INCORRECT PATIENT DATA ENTRY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED A CASE OF A BILATERAL TORIC INTRAOCULAR LENS EXPLANTED, AND INDICATED A DIAGNOSTIC CALCULATION ERROR CREATED AN UNEXPECTED REFRACTIVE OUT-COME. UPON ADDITIONAL FOLLOW UP, THE REPORTER WAS UNWILLING TO PROVIDE ANY ADDITIONAL INFORMATION. THERE ARE TWO RELATED REPORTS FOR THIS PATIENT. THIS REPORT ADDRESSES THE PATIENT'S RIGHT EYE, AND ANOTHER MANUFACTURER REPORT WILL BE FILED FOR THE FELLOW EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415865 VERION REFERENCE UNIT KERATOMETER, PUPILLOMETER HJB WAVELIGHT GMBH (AGPS) X-RUS ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R SN6AT9U165, SP ACRYSOF TORIC IQ