BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERION REFERENCE UNIT

    MDR report key: 5313354 · Received December 21, 2015

    Report

    Report Number
    3010300699-2015-00521
    Event Type
    Malfunction
    Date Received
    December 21, 2015
    Report Date
    February 23, 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
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: SAMPLE WAS NOT RETURNED. PROVIDED DOCUMENTATION HAS BEEN INVESTIGATED. NO TECHNICAL ROOT CAUSE COULD BE DETERMINED, BASED ON THE INFORMATION PROVIDED. PREOP MEASUREMENTS USING THE PRODUCT ASSUME A REGULAR CORNEA OF THE PATIENT¿S EYE. THE PROVIDED INFORMATION OF THE EVENT DESCRIBES THAT A SURGERY WAS PLANNED AND PERFORMED FOR A PATIENT WITH AN IRREGULAR CORNEA DUE TO A PREVIOUS PERFORMED LASIK SURGERY. FOR POST LASIK CASES SPECIFIC IOL CALCULATION METHODS OR FORMULAS SHOULD BE USED TO PROVIDE THE APPROPRIATE IOL POWER. THE ¿ALTERNATE-K¿ FUNCTION IS AVAILABLE FOR THESE CASES. WITH PROVIDED INFORMATION, IT COULD NOT BE DETERMINED, WHICH FORMULA HAS BEEN USED. A MALFUNCTION OF THE DEVICE COULD NOT BE DETERMINED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: 2015-133833

    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. SEVERAL ATTEMPTS WERE MADE TO OBTAIN FURTHER INFORMATION ON THE EVENT WITH NO RESPONSE TO DATE. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: SAMPLE WAS NOT RETURNED. PROVIDED DOCUMENTATION HAS BEEN INVESTIGATED. PREOPERATIVE MEASUREMENTS USING VERION REFERENCE UNIT ASSUME A REGULAR CORNEA OF THE PATIENT¿S EYE. THE PROVIDED INFORMATION OF THE EVENT DESCRIBED THAT A SURGERY WAS PLANNED AND PERFORMED FOR A PATIENT WITH AN IRREGULAR CORNEA DUE TO A PREVIOUS PERFORMED LASIK SURGERY. UNDER THE GIVEN CONDITIONS A CROSS CHECK WITH ALTERNATIVE DIAGNOSTIC DEVICES/METHODS IS RECOMMENDED ACCORDING TO THE USER MANUAL. FOR POST LASIK CASES SPECIFIC INTRAOCULAR LENS (IOL) CALCULATION METHODS OR FORMULAS SHOULD HAVE BEEN USED TO PROVIDE THE APPROPRIATE IOL POWER. ¿ALTERNATE-K¿ FUNCTION IS AVAILABLE IN CASE PREVIOUS LASIK WAS SELECTED AS PRE-EXISTING CONDITION TO CALCULATE THE ALTERNATE K-READINGS THAT SHOULD BE USED FOR APPROPRIATE POST LASIK IOL CALCULATION. NO TECHNICAL ROOT CAUSE COULD BE DETERMINED, BASED ON THE INFORMATION PROVIDED.

    Description of Event or Problem · 1

    A NURSE REPORTED THAT THE SURGEON WAS DISSATISFIED WITH THE INTRAOCULAR LENS (IOL) CALCULATIONS GIVEN BY THE SYSTEM SOFTWARE. THE PATIENT HAD THREE DIOPTERS OF ASTIGMATISM PRIOR TO THE SURGERY. FOLLOWING THE IOL IMPLANT SURGERY, THE PATIENT STILL HAD ONE AND A HALF DIOPTERS OF RESIDUAL ASTIGMATISM. ACCORDING TO THE NURSE, THE PATIENT HAD PREVIOUSLY UNDERGONE LASIK SURGERY, MANY YEARS AGO, AND THIS MADE IT DIFFICULT TO MEASURE THE PATIENT FOR THE IOL CALCULATIONS. SEVERAL ATTEMPTS WERE MADE TO OBTAIN FURTHER INFORMATION ON THE EVENT WITH NO RESPONSE TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842040 VERION REFERENCE UNIT KERATOMETER, PUPILLOMETER HLG WAVELIGHT GMBH (AGPS) X-RUS ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other