BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS LASER

    MDR report key: 2511907 · Received March 30, 2012

    Report

    Report Number
    3006695864-2012-00054
    Event Type
    Injury
    Date Received
    March 30, 2012
    Date of Event
    June 17, 2011
    Report Date
    July 12, 2011
    Manufacturer
    AMO MANUFACTURING USA, LLC.
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: UNABLE TO EVALUATE THE SYSTEM AS IT PERTAINS TO THIS EVENT. THE SYSTEM HAS BEEN SERVICED AND/OR USED SINCE THE REPORTED EVENT AND THE COMPLAINT CANNOT BE CONFIRMED. THE FIELD SERVICE ENGINEER WHO SERVICED THE SYSTEM AFTER THE REPORTED EVENT FOUND THAT THE SYSTEM MET AMO SPECIFICATIONS PRIOR TO LEAVING THE SITE. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED. (B)(4): PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    A CLINICAL DEVELOPMENT MANAGER (CDM) FOLLOWED UP WITH ACCOUNT AND REPORTED PATIENT UNCORRECTED VISUAL ACUITY (UCVA) AT 3 MONTHS POST OPERATION WAS 20/20 IN BOTH EYES (OU) AND THAT NO VISION WAS LOST.

    Description of Event or Problem · 1

    INTRALASE FEMTOSECOND LASER WAS USED TO CREATE A FLAP BOTH EYES (OU) ON (B)(6), 2011. POSTOPERATIVE RESULTS AT 1 WEEK SHOW A BEST CORRECTED VISUAL ACUITY OF 20/30 LEFT EYE (OS) AND 20/40+ RIGHT EYE (OD). THESE VALUES ARE BEST CORRECTED WITH GLASSES OR CONTACTS BEFORE AND AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRALASE FS LASER FEMTOSECOND LASER HNO AMO MANUFACTURING USA, LLC. 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Other