BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFS

    MDR report key: 3189015 · Received June 25, 2013

    Report

    Report Number
    3006695864-2013-00228
    Event Type
    Injury
    Date Received
    June 25, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 30, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): CONCLUSION - THE EQUIPMENT WAS NOT EVALUATED AFTER THE TREATMENT DATE WHICH OCCURRED ON (B)(6) 2013 DUE TO THE FACT ABBOTT MEDICAL OPTICS (AMO) BECAME AWARE ON (B)(6) 2013. THE CONDITION OF THE SYSTEM (SINCE THE TIME OF THE EVENT) WILL MAKE THE EVALUATION DIFFICULT. THE CLINIC DID NOT REQUEST FIELD SERVICE OR CLINICAL SUPPORT.NOTE: ALL PERTINENT INFORMATION AVAILABLE TO AMO AT THE TIME OF THIS REPORT HAS BEEN SUBMITTED. (B)(4): PLACEHOLDER.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED OF FLAP SUTURE PERFORMED ON (B)(6) 2013 DUE TO MUD CRACKS SEEN IN VISUAL AXIS ON PATIENT''S LEFT EYE CAUSING VISUAL DISTORTION AND CONTRAST ISSUES. PATIENT''S UNCORRECTED VISUAL ACUITY (UCVA) WAS 20/20+2 ON (B)(6) 2013. NO LOSS IN VISION REPORTED. DATE OF SURGERY WAS ON (B)(6) 2013. NO MUD CRACKS SEEN ON (B)(6) 2013 AFTER FLAP SUTURE. ALL OTHER PATIENTS TREATED ON (B)(6) 2013 LOOK GREAT AND SUPER HAPPY PER PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288696 IFS FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS J20007D

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other| R