BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR

    MDR report key: 4151322 · Received October 8, 2014

    Report

    Report Number
    3006695864-2014-00436
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    August 14, 2014
    Report Date
    August 26, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    LZS
    PMA / PMN Number
    P930016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING DATE NOT AVAILABLE AT THE TIME OF THIS REPORT. (B)(4). FIELD SERVICE VISITED THE ACCOUNT AFTER THE EVENT AND PERFORMED A SYSTEM CHECKOUT. THE EXCIMER SYSTEM REQUIRED ADJUSTMENT. THE DESIGN SYSTEM WAS ALSO CHECKED AND FOUND THAT TEST EYE B WAS READING HIGHER ON THE SPHERE READING. CHECKED TEST EYE A AND FOUND THAT THE READINGS WHERE WITHIN SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    ACCOUNT REPORTED EXPERIENCING OVERCORRECTIONS. THE PATIENT PRESENTED ONE MONTH POST TREATMENT WITH OVERCORRECTION OF 0.75 DIOPTERS IN RIGHT EYE AND 0.50 DIOPTERS IN LEFT EYE. THE PATIENT ALSO PRESENTED AT 2 WEEKS POST TREATMENT WITH MICRO STRIAE IN HIS RIGHT EYE AND THE FLAP WAS REFLOATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632877 STAR EXCIMER LASER LZS ABBOTT MEDICAL OPTICS 0030-1479

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention IDESIGN AWS SYSTEM G300-1342