BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS3

    MDR report key: 2428165 · Received January 25, 2012

    Report

    Report Number
    3006695864-2012-00006
    Event Type
    Injury
    Date Received
    January 25, 2012
    Date of Event
    December 21, 2011
    Report Date
    December 27, 2011
    Manufacturer
    AMO MANUFACTURING USA, LLC.
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FIELD SERVICE SPECIALIST (FSS) VISITED SITE AFTER THE REPORTED EVENT. HE PERFORMED PREVENTIVE MAINTENANCE AND TECHNICAL SERVICE BULLETIN (ENCODER OPTICAL FACTOR) ON UNIT AND SYSTEM MET AMO SPECIFICATIONS. NOTE: ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS (AMO) AT THE TIME OF THIS REPORT HAS BEEN SUBMITTED. SHOULD NEW INFORMATION THAT CHANGES THE FACTS AND/OR CONCLUSION OF THIS REPORT BECOME AVAILABLE; A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    PATIENT (PT) HAD INITIAL LASIK WITH MECHANICAL MICROKERTOME 10 TO 12 YEARS AGO. UNSURE TYPE OF KERATOME - NASAL HINGE. PT HAD ILASIK ENHANCEMENT (B)(6) 2011. PT PRESENTED AT 1 WEEK POST OP WITH EPI INGROWTH OD AT COMANAGING DOCTORS OFFICE. DR. FOLLOWED PT FOR 3 WEEKS AND REFERRED BACK TO TLC FOR FLAP LIFT AND EPI INGROWTH REMOVAL ON (B)(6) 2011. FLAP LIFTED AND EPITHELIUM REMOVED OD. VASC 20/25 OD RX PRIOR TO FLAP LIFT +1.25 - 0.50 @ 125 20/20 OD. PT REFERRED BACK TO COMANAGING DOCTOR FOR FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRALASE FS3 FEMTOSECOND LASER HNO AMO MANUFACTURING USA, LLC. 20004

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention