BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 2961791 · Received February 14, 2013

    Report

    Report Number
    3006695864-2013-00042
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 18, 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. THE INITIAL PROCEDURE WAS UNEVENTFUL. THE CLINIC REPORTED THIS EVENT ONLY AND DID NOT REQUEST FIELD SERVICE OR CLINICAL SUPPORT.

    Description of Event or Problem · 1

    PATIENT UNDERWENT UNEVENTFUL LASIK ON BOTH EYES (OU) WITH INTRALASE ON (B)(6) 2012. PATIENT WAS REFERRED BACK TO TLC VISION BY PRIMARY EYE CARE PROVIDER FOR EVALUATION OF EPITHELIAL INGROWTH ON RIGHT EYE (OD) ON (B)(6) 2013. VISUAL ACUITY SANS CORRECTED (VASC) WAS 20/25 OD. SURGEON ELECTED TO LIFT FLAP AND REMOVE EPI INGROWTH OD. PROCEDURE DONE ON (B)(6) 2013. VASC ON (B)(6) 2013 WAS 20/20 OD AND 20/20 LEFT EYE (OS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65498 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other| R