BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S4-ETL

    MDR report key: 3945494 · Received July 21, 2014

    Report

    Report Number
    3006695864-2014-00348
    Event Type
    Injury
    Date Received
    July 21, 2014
    Date of Event
    April 10, 2014
    Report Date
    June 16, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    LZS
    PMA / PMN Number
    P930016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MANUFACTURING DATE NOT AVAILABLE AT THE TIME OF THIS REPORT. (B)(4) 2014, APPLICATION SUPPORT MANAGER VISITED ACCOUNT AND OBSERVED SURGEON COMPLETE 1 ILASIK PATIENT (BOTH EYES ) SUCCESSFULLY AND DID NOT SEE ANYTHING TO LEAD TO UNDERCORRECTIONS. CONFIRMED INNER DIAMETER OF SPHERE LESS THAN 0.80. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    ACCOUNT REPORTED RECEIVED SURGEONS HAVE BEEN NOTICING AN INCREASE IN UNDERCORRECTIONS THE LAST FEW MONTHS. WE HAVE CONSIDERED ALL THE POSSIBLE VARIABLES THAT MIGHT ACCOUNT FOR THEM BUT THEY ARE DIFFERENT SURGEONS, DIFFERENT DAYS, DIFFERENT TEAMS, DIFFERENT CORRECTIONS. PATIENT REQUIRED AN ENHANCEMENT PROCEDURE FOR THE CORRECTION OF THE UNDERCORRECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424597 S4-ETL EXCIMER LASER LZS ABBOTT MEDICAL OPTICS 0030-4077

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention