BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AL-SCAN

    MDR report key: 5823563 · Received July 26, 2016

    Report

    Report Number
    3002807715-2016-00031
    Event Type
    Injury
    Date Received
    July 26, 2016
    Date of Event
    August 17, 2015
    Report Date
    August 17, 2015
    Manufacturer
    NIDEK CO., LTD.
    Product Code
    HJB
    PMA / PMN Number
    K133132
    Removal / Correction Number
    2936921-7/01/2016-001-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS NOT BEEN EVALUATED IN THIS CASE. HOWEVER, BASED ON THE INVESTIGATION INCLUDING INTERNAL TEST, THE NCO WAS ABLE TO DUPLICATE THE SIMILAR UNUSUAL AXIAL LENGTH AND WAVEFORMS BY ELECTRONIC DISCHARGE EXCEEDED THE CRITERIA. THE NCO CONSIDERED EXTERNAL ELECTROMAGNETIC DISTURBANCE IN ABNORMAL OPERATING CONDITIONS POSSIBLY MAY HAVE CAUSED TO AL-SCAN WHICH CONFORMS TO INTERNATIONAL STANDARDS FOR ELECTROMAGNETIC COMPATIBILITY OF MEDICAL DEVICE AND HAS BEEN VERIFIED TO OPERATE PROPERLY UNDER NORMAL OPERATING CONDITION. IN ORDER TO PREVENT THE INCIDENT IN CUSTOMER SITE IN THE UNITED STATES, NCO REQUESTED NIDEK INC. WHICH IS USA SUBSIDIARY OF NCO TO ALERT TO THIS SYMPTOM AND ALSO RECOMMENDED THAT THE SOFTWARE SHOULD BE UPGRADED WITH THE NEW VERSION.RECALL HAS BEEN INITIATED BY US UNDER RECALL REPORT NUMBER :2936921-7/01/2016-001-C. TWO PATIENTS WERE AFFECTED SO TWO SEPARATE MDRS WILL BE SUBMITTED FOR EACH EVENT. PLEASE REFER TO AL-SCAN (B)(4) RECALL INJURY 3002807715-2016-00030, AL-SCAN (B)(4) RECALL INJURY 3002807715-2016-00031.

    Description of Event or Problem · 1

    THE MANUFACTURER,NIDEK CO., LTD.(ABBREVIATED: NCO) RECEIVED FOLLOWING INFORMATION FROM AN AUTHORIZED DISTRIBUTOR BY NCO IN (B)(4). THE AXIAL LENGTH OF 2 PATIENTS ARE MEASURED 20.6MM IN EACH EYE. IOL +32D AND +33D WERE INSERTED FOR THOSE PATIENTS AS RECOMMENDED ACCORDING TO THE IOL POWER FORMULA. HOWEVER, THOSE PATIENTS GOT NEARSIGHTED BY -9D AFTER THE SURGERY. BEFORE THE SURGERY, THE QUALITY OF THE SCANNING OF AL-SCAN WERE GOOD WITH HIGH SIGNAL TO NOISE RATIO. THERE WERE NO CORNEAL OPACITIES AND IT WAS A STANDARD CATARACT IN A LOW HYPEROPIA. AFTER THE SURGERY, THE AXIAL LENGTH WAS MEASURED AGAIN AND ALL FOUR EYES RESULTED IN 23.3-23.6MM. BOTH PATIENTS NEED IOL REPLACEMENT. NO SUCH ISSUES HAVE BEEN OCCURRED IN THE PAST EXCEPT THESE TWO PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474429 AL-SCAN OPTICAL BIOMETER HJB NIDEK CO., LTD. AL-SCAN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention