BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 2970044 · Received February 20, 2013

    Report

    Report Number
    3006695864-2013-00054
    Event Type
    Injury
    Date Received
    February 20, 2013
    Date of Event
    December 9, 2012
    Report Date
    January 21, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) -ON (B)(4) 2013, CUSTOMER REPORTED THE OUTCOME FOR THE STAGE 1 DLK CASES. (B)(4): PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    EVALUATION 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. 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. AMO'S CLINICAL DEVELOPMENT MANAGER (CDM) CONTACTED THE CUSTOMER. CDM INFORMED THE CUSTOMER THAT USE OF A GENERIC STEROID DROPS INCREASES THE RISK OF DLK. PLACEHOLDER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED 2 CASES OF STAGE 1 DIFFUSE LAMELLAR KERATITIS (DLK). PATIENT HAD DLK ON THE RIGHT EYE (OD). CUSTOMER TREATED PATIENT WITH PREDNISOLONE ACETATE DROPS. UNCORRECTED VISUAL ACUITY (VA) ON (B)(6) 2012, OD WAS 20/15. ON (B)(6) 2012, CUSTOMER REPORTED THE OUTCOME FOR THE STAGE 1 DLK CASES. DATE OF SURGERY WAS PERFORMED ON (B)(6) 2012, FOR BOTH PATIENTS. DLK WAS NOTICED ON (B)(6) 2012, FOR BOTH PATIENTS. DLK WAS RESOLVED ON BOTH PATIENTS ON (B)(6) 2012. PRED FORTE 1% WAS USED TO TREAT DLK FOR BOTH PATIENTS. NO LOSS IN VISION; BEST CORRECTED VISUAL ACUITY (BCVA) WAS 20/20 PRE- AND POST-OPERATIVELY FOR BOTH PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74166 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20005D

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Other