BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 3130608 · Received May 24, 2013

    Report

    Report Number
    3006695864-2013-00181
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    October 20, 2012
    Report Date
    March 7, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, CONCLUSION - THE EQUIPMENT WAS NOT EVALUATED AFTER THE TREATMENT DATE WHICH OCCURRED ON (B)(6) 2012 DUE TO THE FACT ABBOTT MEDICAL OPTICS (AMO) BECAME AWARE ON (B)(6) 2013. THE CONDITION OF THE SYSTEM (SINCE THE TIME OF THE INITIAL PROCEDURE) WILL MAKE THE EVALUATION DIFFICULT. CUSTOMER IS ONLY REPORTING THIS EVENT AND DID NOT REQUEST FIELD SERVICE OR CLINICAL SUPPORT. NOTE: ALL PERTINENT INFORMATION AVAILABLE TO AMO AT THE TIME OF THIS REPORT HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE - TREATMENT DATE WAS ON (B)(6) 2011. ENHANCEMENT DATE WAS ON (B)(6) 2012. FLAP LIFT FOR EPITHELIAL REMOVAL WAS ON (B)(6) 2012. THE EPITHELIAL ISSUE WAS DUE TO THE INGROWTH. THE STRIAE AND THE EPITHELIAL ISSUE RESOLVED. THERE WAS NO LOSS OF VISION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED FLAP STRIAE ON PATIENT'S LEFT EYE. STATUS/POST LIFT FOR EPITHELIAL REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232225 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20005D

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other| R