BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 3173866 · Received June 17, 2013

    Report

    Report Number
    3006695864-2013-00218
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 20, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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) 2013, 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 DID NOT REQUEST FIELD SERVICE OR CLINICAL SUPPORT. PLACEHOLDER.

    Description of Event or Problem · 1

    PATIENT ON 10 DAY POST OP, HAD STRIAE ON THE LEFT EYE. LEFT EYE WAS LIFTED AND RINSED. PATIENT WAS TREATED WITH DUREZOL. PATIENT EXPERIENCED LOSS OF BEST CORRECTED VISUAL ACUITY. UNCORRECTED VISUAL ACUITY (UCVA) ON (B)(6) 2013, WAS 20/20 ON THE RIGHT EYE AND 20/30 ON THE LEFT EYE. BEST CORRECTED VISUAL ACUITY (BCVA) ON (B)(6) 2013, WAS 20/20 ON THE RIGHT EYE AND 20/20 ON THE LEFT EYE. PATIENT STATED LEFT EYE BLURRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274169 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20005D

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other| R