BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 3146074 · Received June 4, 2013

    Report

    Report Number
    3006695864-2013-00192
    Event Type
    Injury
    Date Received
    June 4, 2013
    Date of Event
    April 12, 2013
    Report Date
    May 7, 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) 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 REPORTED THIS EVENT ONLY AND DID NOT REQUEST FIELD SERVICE OR CLINICAL SUPPORT. CUSTOMER BELIEVES THAT THE EVENT IS THOUGHT TO BE CAUSED BY THE BESIVANCE GETTING UNDER LOOSE EPITHELIUM POST TREATMENT. PATIENT HAD LOOSE EPI POST TREATMENT WITH NO COMPLICATIONS FROM THE SURGERY. PLACEHOLDER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED INFECTION/INFLAMMATION ON BOTH EYES. PATIENT WAS TREATED WITH LOTEMAX GEL/PRED ACETATE. FROM DAY ONE PATIENT STATES BLURRY VISION, PHOTOPHOBIA. SLIT LAMP EXAM REVEALED LOOSE EPITHELIUM ON BOTH EYES. PATIENT STATES NEEDS TO REST EYES FREQUENTLY AND CANNOT DRIVE LONG DISTANCES. VISION IS BLURRY WITH SOME PHOTOPHOBIA. UNCORRECTED VISUAL ACUITY WAS 20/25-2 ON THE RIGHT EYE AND 20/60+1 ON THE LEFT EYE. BEST CORRECTED VISUAL ACUITY WAS 20/20-2 ON THE RIGHT EYE AND 20/25+1 ON THE LEFT EYE. PATIENT EXPERIENCED LOSS OF BEST CORRECTED VISUAL ACUITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246037 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other