BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2 LASER

    MDR report key: 2072605 · Received April 20, 2011

    Report

    Report Number
    3006695864-2011-00029
    Event Type
    Injury
    Date Received
    April 20, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 21, 2011
    Manufacturer
    AMO MANUFACTURING USA, LLC.
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT FOLDER (B)(4). (B)(4) (SUTURE). EVALUATION: CLINICAL DEVELOPMENT MANAGER (CDM) WAS ON SITE AND RECOMMENDED THE SURGEON LIFTING TECHNIQUE CHANGES THAT MAY HELP. CLINICAL ATTEMPTED TO GET ADDITIONAL INFO RELATED TO THE PT OUTCOME FROM THE ACCOUNT ON 03/10/2011, 3/14/2011, AND 03/21/2011 AND IT WAS ALWAYS AVOIDED; NO ADDITIONAL INFO WAS PROVIDED. SURGEON SAID TO CDM THAT SHE WILL NOT BE REPORTING SINCE (THE PROBLEM) IS NOT A COMPLICATION FROM THE IL (INTRALASE). THAT SHE (SURGEON) HAD NEVER REPORTED EPITHELIAL INGROWTH IN THE PAST.

    Description of Event or Problem · 1

    SURGERY SUPPORT TO INVESTIGATE COMPLAINT OF EPITHELIAL IN-GROWTH POST ILSE (INTRALASE) PROCEDURE. SURGEON REPORTED SHE HAD SUCCESSFULLY TREATED ALL THE EPITHELIAL IN-GROWTH. SURGEON REPORTED HAS GOOD VISION ON ALL THE PTS EXCEPT ONE THAT SHE HAD TO SUTURE. PT HAS ASTIGMATISM THAT SURGEON EXPECT WILL RESOLVE OVER THE NEXT MONTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRALASE FS2 LASER HNO AMO MANUFACTURING USA, LLC. 20005D

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention