BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 2962053 · Received February 14, 2013

    Report

    Report Number
    3006695864-2013-00046
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    January 10, 2013
    Report Date
    March 6, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT HAD CONSULTATION ON (B)(6) 2013. PATIENT WAS DIAGNOSED WITH SIGNIFICANT DRY EYE SYNDROME AND HAD AN INFILTRATE UNDER THE RIGHT FLAP. THE INFILTRATE WAS SCRAPED AND CULTURED. NO GROWTH WAS FOUND. THE INFILTRATE HAS SINCE DISSIPATED. PATIENT WAS GIVEN UPPER AND LOWER PUNCTAL PLUGS AND PRESCRIBED TOPICAL RESTASIS. SHE REQUIRED INTERMITTENT BANDAGE CONTACT LENSES TO HELP WITH THE EPITHELIAL BREAKDOWN. ON (B)(6) 2013, PHYSICIAN EXAMINED PATIENT AND FOUND UNCORRECTED VISUAL ACUITY (VA) TO BE 20/20 RIGHT EYE AND 20/30+ IN THE LEFT EYE. HOWEVER, THE PATIENT STILL HAD A BANDAGE CONTACT LENS IN THE LEFT EYE WHEN THE VA WAS DONE. THE LENS WAS REMOVED BEFORE THE PATIENT LEFT THE OFFICE. PATIENT IS BEING TREATED FOR DRY EYE ON BOTH EYES WITH PLUGS AND RESTASIS. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    CONCLUSION CODE - 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)(6) 2013. THE CONDITION OF THE SYSTEM (SINCE THE TIME OF THE EVENT) WILL MAKE THE EVALUATION IMPOSSIBLE. THE CLINIC REPORTED THIS EVENT ONLY AND DID NOT REQUEST FIELD SERVICE OR CLINICAL SUPPORT.

    Description of Event or Problem · 1

    ON DAY 1 POST-OP VISUAL ACUITY (VA) WAS 20/20 ON BOTH EYES (OU) AND CORNEA CLEAR OU. DAY 3, PATIENT COMPLAINING OF PAIN, DECREASED VA. SEEN BY OPTOMETRIST AND CORNEAL ABRASION ON THE RIGHT EYE (OD) WAS NOTED. NO FLAP INVOLVEMENT. BANDAGE CONTACT LENS (BCL) PLACED, CYCLOGEL 1%. SURGEON FELT THAT THE ABRASION MAY HAVE BEEN THE RESULT OF SEVERE POST LASIK DRYNESS. DAY 4, LOOSE EPITHELIAL NOTED AND HEALING ABRASION. DAY 5, STAGE 1 DIFFUSE LAMELLAR KERATITIS DLK AND NO EPITHELIAL DEFECT. PATIENT TREATED WITH PRED FORTE AND TOBRADEX. ON DAY 6 PATIENT WAS REFERRED TO A CORNEAL SPECIALIST. THE CORNEAL SPECIALIST DID A FLAP LIFT AND RINSE. PATIENT WAS IMPROVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65560 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20005D

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other| R