BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 2993341 · Received March 7, 2013

    Report

    Report Number
    3006695864-2013-00078
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    January 11, 2013
    Report Date
    February 6, 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) 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 IMPOSSIBLE. CUSTOMER INDICATED THAT THE PROCEDURE WAS UNEVENTFUL AND IS ONLY REPORTING THIS EVENT. CUSTOMER DID NOT REQUEST FIELD SERVICE OR CLINICAL SUPPORT.

    Description of Event or Problem · 1

    PATIENT UNDERWENT UNEVENTFUL ILASIK ON (B)(6) 2012. ON (B)(6) 2013, MACRO STRIAE WAS IDENTIFIED ON THE RIGHT EYE (OD). LIFT AND STRETCH WAS PERFORMED ON (B)(6) 2013. BANDAGE CONTACT LENS (BCL) PLACED OD POST LIFT AND STRETCH. ON (B)(6) 2013, VISUAL ACUITY SANS CORRECTION (VASC) WAS 20/25 OD AND 20/20 LEFT EYE (OS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97239 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20003

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other| R