BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERION REFERENCE UNIT

    MDR report key: 4871813 · Received June 26, 2015

    Report

    Report Number
    3010300699-2015-00506
    Event Type
    Injury
    Date Received
    June 26, 2015
    Date of Event
    June 25, 2014
    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. (B)(4).

    Additional Manufacturer Narrative · 1

    NO TECHNICAL ROOT CAUSE COULD BE DETERMINED, BASED ON THE INFORMATION PROVIDED. 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 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415881 VERION REFERENCE UNIT KERATOMETER, PUPILLOMETER HJB WAVELIGHT GMBH (AGPS) X-RUS ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R SN6AT4.220, SP ACRYSOF TORIC IQ