BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 2973086 · Received February 21, 2013

    Report

    Report Number
    3006695864-2013-00056
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 23, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION - 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 OF THE PATIENT'S PROLONGED STATUS OF DRY EYE AND BLURRED VISION. 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 (B)(6) 2012, CUSTOMER NOTED TRANSIENT LIGHT SENSITIVITY SYNDROME AND DRY EYE ON A PATIENT WHO WAS TREATED ON (B)(6) 2012. PATIENT WORKS ON COMPUTER 8-12 HOURS PER DAY. HER EYES FELT DRY, SHE WAS SENSITIVE TO LIGHT, AND HER VISION FELT BLURRY AT DISTANCE AND NEAR. SHE WAS GOING TO USE A LOW DOSE STEROID WHEN A GRADUAL MONTH LONG TAPER ALONG WITH LUBRICANT DROPS EVERY HOUR, RESTASIS THREE TIMES PER DAY, AND LUBRICANT OINTMENT AT NIGHT. PRE-OP UNCORRECTED VISUAL ACUITY (UCVA) WAS 20/20-2 RIGHT EYE (OD) AND 20/20-1 LEFT EYE (OS). POST-OP UCVA WAS 20/25+3 OD AND 20/25+2 OS. PRE-OP BEST SPECTACLE CORRECTED VISUAL ACUITY (BSCVA) WAS 20/25+3 OD AND 20/25+2 OS. POST-OP BSCVA WAS 20/25+3 OD AND 20/25+2 (OS). ON (B)(6) 2013, PATIENT FOLLOW UP INFORMATION WAS RECEIVED. THE TRANSIENT LIGHT SENSITIVITY SYNDROME WAS RESOLVED. THE DRY EYE DID NOT RESOLVE. THE SYMPTOMS SIGNIFICANTLY INTERFERE WITH THEIR ACTIVITIES OF DAILY LIVING. THE PATIENT STATED "DISTANCE VISION FEELS OK, BUT NEAR VISION IS HARD ESPECIALLY FINE PRINT (COMPUTERS, CELL PHONE)". THERE HAS BEEN NO VISION LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75501 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20005D

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other