BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 3160492 · Received June 10, 2013

    Report

    Report Number
    3006695864-2013-00201
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    May 5, 2013
    Report Date
    May 16, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    PATIENT CALLED THE DOCTOR COMPLAINING OF PAIN AND BLURRY VISION ON THE LEFT EYE. PATIENT WAS SEEN IN OFFICE THAT DAY AND WAS DISCOVERED TO HAVE A CENTRAL ABRASION. ADDITIONAL FOLLOW-UP WAS OBTAINED. IT TOOK MORE THAN A WEEK TO HEAL, AND THERE WAS NO SURGICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260867 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other