BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVESCAN WS1

    MDR report key: 3202827 · Received July 2, 2013

    Report

    Report Number
    3006695864-2013-00246
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    April 29, 2013
    Report Date
    June 14, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    LZS
    PMA / PMN Number
    P930016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE AMO FIELD SERVICE ENGINEER EVALUATED THE SYSTEM AT THE CUSTOMER'S LOCATION. NO ISSUES WERE FOUND WITH THE SYSTEM THAT WOULD RELATE TO THE OVER CORRECTION HOWEVER FIELD SERVICE REPLACED THE WAVESCAN HEAD DUE TO AN INTERNAL REFLECTION OF OVER 8 DIOPTERS. PLACEHOLDER.

    Description of Event or Problem · 1

    THE CLINIC REPORTED THAT A LASER VISION CORRECTION PATIENT PRESENTED WITH AN OVER CORRECTED VISION OF 1/4 TO 1.5 DIOPTER SPHERE. THE PATIENT'S BEST CORRECTED VISUAL ACUITY WAS 20/25 AND 20/30.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302041 WAVESCAN WS1 REFRACTIVE MEASUREMENT LZS ABBOTT MEDICAL OPTICS WS1

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other