BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS1 LASER

    MDR report key: 2115464 · Received May 26, 2011

    Report

    Report Number
    3006695864-2011-00043
    Event Type
    Injury
    Date Received
    May 26, 2011
    Date of Event
    April 28, 2011
    Report Date
    May 12, 2011
    Manufacturer
    AMO MANUFACTURING USA, LLC.
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EPITHELIAL INGROWTH WITH CORNEAL MELT. EVALUATION: FIELD SERVICE SPECIALIST (FSS) CHECKED SYSTEM ON (B)(4) 2011 AND COMPLETED QUARTERLY PREVENTATIVE MAINTENANCE, VERIFIED ENERGY READINGS AND CLEANED OPTICS. PERFORMED A Z-OFFSET CALIBRATION AND DID ADJUSTMENT. SYSTEM MEETS ALL AMO SPECS.

    Description of Event or Problem · 1

    LIFT FLAP ENHANCEMENT PROCEDURE (B)(6) 2010. DURING FOLLOW-UP VISITS WITH COMANAGING OPTOMETRIST, AFFILIATE NOTED LATE EPITHELIAL INGROWTH OD. RE-LIFT/REMOVAL SCHEDULED FOR (B)(6) 2011. VASC PRIOR TO EPI REMOVAL 20/30 +2. ON (B)(6) 2011, 1 WEEK POST OP, VASC OD 20/20 NO EPI INGROWTH NOTED. REFERRED BACK TO AFFILIATE FOR CONTINUED CARE. (B)(4) USED DURING ENHANCEMENT, INTRALASE USED FOR FLAP CREATION DURING PRIMARY PROCEDURE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRALASE FS1 LASER HNO AMO MANUFACTURING USA, LLC. 20002

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention