BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR S4-IR-CE EXCIMER LASER

    MDR report key: 3222359 · Received July 12, 2013

    Report

    Report Number
    3006695864-2013-00264
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    May 23, 2013
    Report Date
    June 26, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    LZS
    PMA / PMN Number
    P930016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF THE REPORT. (B)(6) 2013. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER DID NOT SUSPECT THE EQUIPMENT AND INDICATED THAT IT WAS WORKING FINE. FIELD SERVICE WAS NOT REQUESTED FOR THIS EVENT. THE AMO CLINICAL DEVELOPMENT MANAGER (CDM) WAS ON SITE FOR A CLINICAL OPTIMIZATION WITH THE CUSTOMER AND WAS ADVISED ON THE ONE PATIENT WITH AN OVER CORRECTED VISION. THE CDM PROVIDED OPERATIONAL SUPPORT TO THE CLINIC STAFF AND SURGEON. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED. (B)(4): PLACEHOLDER.

    Description of Event or Problem · 1

    THE CLINIC REPORTED THAT A LASER VISION CORRECTION PATIENT PRESENTED WITH AN OVER CORRECTED TREATMENT AT A POST OP EXAM OF +3.50 DIOPTER IN THE LEFT EYE.THE PATIENT''S POST OP BEST CORRECTED VISUAL ACUITY IS UNCHANGED FROM THEIR PRE OP BEST CORRECTED VISUAL ACUITY OF 20/25

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323320 STAR S4-IR-CE EXCIMER LASER EXCIMER LASER LZS ABBOTT MEDICAL OPTICS STAR S4-IR-CE

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other