BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFS

    MDR report key: 3230342 · Received July 16, 2013

    Report

    Report Number
    3006695864-2013-00269
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    May 1, 2013
    Report Date
    June 19, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - (STRIAE) EVALUATION: THE BED DEPTH WAS AT 110. SURGEON WANTED TO CHANGE THE SETTINGS TO 120 DUE TO STRIAE. AMO'S CLINICAL DEVELOPMENT MANAGER (CDM) INSTRUCTED THE SURGEON ON HOW TO CHANGE THE BED THICKNESS. CDM ADVISED THAT IT WAS NOT NECESSARY TO CHANGE ANY OTHER SETTINGS WHEN CHANGING FLAP THICKNESS. SURGEON WANTED TO KNOW IF CHANGING SIDE-CUT ANGLE WOULD AFFECT STRIAE. CDM ADVISED HER ON THE BENEFITS OF THE INVERTED SIDE-CUT, BUT CDM WAS NOT AWARE OF ANY CHANGE IN THE INCIDENCE OF STRIAE BETWEEN 70 OR INVERTED SETTINGS. SURGEON USUALLY USES 120 SIDE-CUT BUT THE CASES WITH STRIAE HAD 70. SURGEON IS GOING TO CHANGE IT BACK TO 120. CDM ALSO ADVISED SURGEON TO SPEAK WITH AMO'S MEDICAL MONITOR.

    Description of Event or Problem · 1

    SURGEON REPORTED 3 PATIENTS WITH STRIAE LOCATED ON THE LEFT EYE ONLY. SURGEON REQUESTED INFORMATION ON HOW TO CHANGE THE BED THICKNESS. SURGEON HAD TO RE-FLOAT THE THREE EYES TO TREAT THE STRIAE BUT REPORTED GOOD RESULTS. THERE WAS NO LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA). FIRST PATIENT HAD THE INITIAL PROCEDURE ON (B)(6) 2013. THE RE-LIFT WAS PERFORMED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328948 IFS FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS J20007D

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R