BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERION REFERENCE UNIT

    MDR report key: 4995222 · Received August 12, 2015

    Report

    Report Number
    3010300699-2015-00513
    Event Type
    Malfunction
    Date Received
    August 12, 2015
    Report Date
    January 29, 2016
    Manufacturer
    WAVELIGHT GMBH (AGPS)
    Product Code
    HLG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE CLOCK START DATE ON THE MDR WAS ORIGINALLY REPORTED AS (B)(6) 2015. THE CORRECT DATE SHOULD HAVE BEEN (B)(6) 2015.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICE HAS NOT BEEN RETURNED, HOWEVER DATA COLLECTION OF THE DEVICE WAS PERFORMED AND ANALYZED BY CLINICAL APPLICATION SPECIALISTS. NO ANOMALIES FOUND BY REVIEW OF DEVICE HISTORY RECORD. PRODUCT MET ALL SPECIFICATIONS WHEN RELEASED. DATA OF (B)(4) MEASUREMENTS WERE PROVIDED AND ANALYZED. THESE SHOWED THAT ONLY (B)(4) MEASUREMENTS COULD BE COMPARED AGAINST THE PREVIOUS SOFTWARE VERSION, ALL OTHERS DID NOT PROVIDE GREEN TRAFFIC LIGHT AND THEREFORE WERE NOT RECOMMENDED TO BE USED. THE DIFFERENCE IN MEASUREMENTS OF SW 2.5.0 AND 2.6 DIFFERS BY 0,2 - 0,5 D WHICH IS WITHIN ACCEPTED LIMITS. COMPARING PREOPERATIVE MEASUREMENTS WITH POSTOPERATIVE MEASUREMENTS INHERENTLY DIFFER BY NATURE OF THE SURGERY AND ITS HEALING PROCESS. NO TECHNICAL ROOT CAUSE COULD BE DETERMINED.

    Description of Event or Problem · 1

    AN OPHTHALMIC SURGEON REPORTED THAT THERE WAS AN ISSUE IN THE MEASUREMENTS REPEATEDLY. PATIENTS' AND EMPLOYEES' MEASUREMENTS COULD NOT BE REPEATED. THERE WERE DIFFERENCES FROM 1 TO 1.5 D. THE PATIENTS' MEASUREMENTS WERE COMPARED WITH A DIFFERENT DEVICE AND THE MEASUREMENTS WERE THE SAME AS THE PREVIOUS ONES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529568 VERION REFERENCE UNIT KERATOMETER, PUPILLOMETER HLG WAVELIGHT GMBH (AGPS) X-RUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other