BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 3211661 · Received July 8, 2013

    Report

    Report Number
    3006695864-2013-00263
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 13, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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)(4) 2013. THE CONDITION OF THE SYSTEM (SINCE THE TIME OF THE EVENT) WILL MAKE THE EVALUATION DIFFICULT. THE CLINIC IS REPORTING THIS EVENT ONLY AND DID NOT REQUEST FIELD SERVICE OR CLINICAL SUPPORT. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    PATIENT CHIEF COMPLAINT WAS TRANSIENT LIGHT SENSITIVITY SYNDROME (TLSS). PLACEHOLDER.

    Description of Event or Problem · 1

    PATIENT STATES STILL HAS DIFFICULTIES WITH PHOTOPHOBIA. PATIENT WAS SEEN FOR 1 DAY, 1 WEEK AND THEN JUST RETURNED 7 MONTHS POST OP. PATIENT STATES VISION IS GOOD STILL HAS TROUBLE WITH LIGHTS. UNCORRECTED VISUAL ACUITY ON (B)(6) 2013, WAS 20/20 ON THE RIGHT EYE AND 20/50 (MONO VISUAL ACUITY) ON THE LEFT EYE. BEST CORRECTED VISUAL ACUITY (BCVA) ON (B)(6) 2013, 20/20 ON THE RIGHT EYE AND 20/20 ON THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309031 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other