BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS3

    MDR report key: 3092474 · Received May 3, 2013

    Report

    Report Number
    3006695864-2013-00148
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    March 7, 2013
    Report Date
    April 3, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 INITIAL PROCEDURE) WILL MAKE THE EVALUATION DIFFICULT TO DETERMINE. CUSTOMER INDICATED THAT INITIAL PROCEDURE WAS UNEVENTFUL AND IS ONLY REPORTING THIS EVENT. CUSTOMER DID NOT REQUEST FIELD SERVICE OR CLINICAL SUPPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2013, PATIENT UNDERWENT UNEVENTFUL ILASIK ON BOTH EYES. PRESENTED AT (B)(6) 2013 EXAM WITH EPITHELIAL INGROWTH ON THE RIGHT EYE. VISUAL ACUITY SANS CORRECTION (VASC) WAS 20/20 BUT HAZY. PATIENT BROUGHT TO THE LASER SUITE. FLAP WAS LIFTED AND INGROWTH REMOVED. AT 1 DAY POST OP. VASC WAS 20/25 WITH NO INGROWTH NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194116 INTRALASE FS3 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20004

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other| R