BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 2993248 · Received March 7, 2013

    Report

    Report Number
    3006695864-2013-00076
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 10, 2012
    Report Date
    February 6, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION - THE EQUIPMENT WAS NOT EVALUATED AFTER THE TREATMENT DATE WHICH OCCURRED ON (B)(6) 2011 DUE TO THE FACT ABBOTT MEDICAL OPTICS (AMO) BECAME AWARE ON (B)(6) 2013. THE CONDITION OF THE SYSTEM (SINCE THE TIME OF THE INITIAL PROCEDURE) WILLMAKE THE EVALUATION IMPOSSIBLE. CUSTOMER INDICATED THAT THE PROCEDURE WAS UNEVENTFUL AND IS ONLY REPORTING THIS EVENT. CUSTOMER DID NOT REQUEST FIELD SERVICE OR CLINICAL SUPPORT.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT UNCOMPLICATED LASIK ON BOTH EYES (OU), ON (B)(6) 2011. PATIENT WAS FOLLOWED BY HIS CO-MANAGING DOCTOR BUT RETURNED TO THE CENTER ON (B)(6) 2012. PATIENT'S FLAP HAD HEALED AS EXPECTED. PATIENT WAS TREATED FOR DRY EYE AND BLEPHARITIS BUT EVEN WITH AN IMPROVED TEAR LAYER HIS COMPLAINTS OF NIGHT GLARE PERSIST. THOUGHT NO OBVIOUS DAMAGE TO A STRUCTURE, THE PATIENT DOES REPORT THAT THE QUALITY OF THE VISION MAY IMPACT HIS DAILY LIVING. PRE-OP PRESCRIPTION RX = -4.00 SPHERE 20/20 RIGHT EYE (OD), -4.25 SPHERE 20/20 LEFT EYE (OS) R''S 43.50/43.75 OD, 43.75/44.25 OS. TREATMENT OD = 4.00 SPHERE, OS -4.00 SPHERE INTRALASE 105UM FLAP. ON (B)(6) 2013, VISUAL ACUITY SANS CORRECTION WAS 20/20 OD, 20/20 OS. RXM PLANO=0.25 X 090 20/20 OD, PLANO 20/20 OS. PREVIEW LENS IMPROVED GLARE OU ''BY 50%'' BUT PATIENT DOES NOT WANT TO RISK ADDITIONAL SURGERY. CUSTOMER WILL CONSIDER FITTING WITH GAS PERMEABLE CONTACT LENS (GPCL) IF PATIENT DESIRES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97993 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20003

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other