BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 3253339 · Received July 29, 2013

    Report

    Report Number
    3006695864-2013-00305
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    July 3, 2013
    Report Date
    July 5, 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) - (STRIAE). EVALUATION: THE EQUIPMENT WAS NOT EVALUATED AFTER THE TREATMENT SINCE THERE WAS NO INDICATION THAT A MALFUNCTION CAUSED THE REPORTED ISSUE. THE CLINIC IS REPORTING THIS EVENT ONLY AND DID NOT REQUEST FIELD SERVICE OR CLINICAL SUPPORT. AMO'S FIELD SERVICE ENGINEER (FSE) VISITED THE SITE ON (B)(6) 2013 FOR PREVENTIVE MAINTENANCE AND DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE EVENT.

    Description of Event or Problem · 1

    PATIENT NOTED TO HAVE STRIAE ON THE RIGHT EYE AND BEST CORRECTED VISUAL ACUITY (BCVA) WAS 20/50. FIRST BROUGHT TO SURGEON'S ATTENTION ON (B)(6) 2013. RECOMMENDED FLAP LIFT/REPOSITION ACUTE RIGHT EYE. PROCEDURE PERFORMED ON (B)(6) 2013. FLAP WELL APPOSED AT CLOSE OF PROCEDURE. BANDAGE SOFT CONTACT LENS (BSCL) PLACED OVER ANTIBIOTIC, STEROID AND NONSTEROIDAL ANTI-INFLAMMATORY DRUG (NSAID) DROPS. PATIENT STARTED ON MEDROL DOSE PACK FOR DIFFUSE LAMELLAR KERATITIS (DLK) PROPHYLAXIS. PATIENT EXPERIENCED LOSS OF BCVA ON THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354037 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other| R