BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2 LASER

    MDR report key: 2193358 · Received July 29, 2011

    Report

    Report Number
    3006695864-2011-00069
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    June 30, 2011
    Report Date
    July 1, 2011
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - (DLK - STAGE UNKNOWN). EVALUATION: EQUIPMENT WAS CHECKED BY A FIELD SERVICE SPECIALIST AND PREVENTATIVE MAINTENANCE WAS DONE ON (B)(6) 2011. NO PROBLEMS WERE FOUND AND SYSTEM MEETS ALL AMO SPECIFICATIONS. CLINICAL DEVELOPMENT MANAGER (ADM) REFERRED SURGEON TO MEDICAL MONITOR AND THE LAST ONE ADVISED SURGEON TO ADJUST SPOT/LINE AND BED ENERGY. AFTER ADJUSTMENTS NO DLK HAS BEEN REPORTED. CDM ATTEMPTED THREE TIMES WITH THE ACCOUNT TO GET INFORMATION REGARDING THE PATIENTS AND NO INFO WAS PROVIDED. NOTE: AS OF THE DATE OF THIS REPORT, AMO HAS PROVIDED ALL AVAILABLE INFORMATION. NO FURTHER INFORMATION IS AVAILABLE OR EXPECTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT FOUR PATIENTS EXPERIENCED DLK IN OD ONLY. REPORTED ALSO STATED THAT THEY DON'T THINK IS INTRALASE RELATED. ONLY ONE PATIENT HAD FLAP LIFT AND RINSE ON (B)(6) 2011. THE CONDITION OF THE OTHER PATIENTS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRALASE FS2 LASER HNO AMO MANUFACTURING USA, LLC 20003

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention