BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS1 LASER

    MDR report key: 2163526 · Received November 10, 2010

    Report

    Report Number
    3006695864-2010-00122
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    July 9, 2010
    Report Date
    October 8, 2010
    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). NOTE: DATE OF INITIAL SURGERY WAS NOT PROVIDED BY COMPLAINT REPORTER. (B)(4), (EPITHELIAL IN-GROWTH). EVALUATION: EQUIPMENT WAS EVALUATED BY A FIELD SERVICE ENGINEER (FSE) AFTER THE EVENT. MECHANICAL AND PERFORMANCE TEST WERE PERFORMED INCLUDING A VISUAL EXAMINATION. FSE COMPLETED THE SCHEDULED QUARTERLY PREVENTIVE MAINTENANCE. AS PART OF THE PREVENTIVE MAINTENANCE DID A CPU BATTERY REPLACEMENT AND A UPS BACKUP BATTERY REPLACEMENT. SYSTEM WAS WORKING ACCORDING TO SPECIFICATIONS.

    Description of Event or Problem · 1

    AFFILIATE DOCTOR REFERRED PATIENT BACK TO TLC CENTER FOR IN-GROWTH EVALUATION ON (B)(6) 2010. VISUALLY SIGNIFICANT EPITHELIAL IN-GROWTH OD WAS NOTED AT TLC EXAM. DISCUSSED FINDINGS AND TREATMENT OPTIONS VS NO TREATMENT. PATIENT ELECTED TO PROCEED WITH LIFTING FLAP, REMOVING EPITHELIAL IN-GROWTH (EIG) AND SUTURING FLAP (LIVES 2.5 HOURS FROM CENTER). EIG LIFT/SCRAPE/SUTURING COMPLETED WITHOUT COMPLICATION. RTC 1 D FOR FOLLOW UP (BLC ALSO PLACED). DURING RTF - ON (B)(6) 2010, IT WAS NOTED THAT THIS EVENT WAS MDR REPORTABLE AND A REPORT HAD NOT BEEN SUBMITTED SO IT IS BEING SENT NOW. CURRENT STATUS - VASC OD 20/25 RXM +.75 25/25, VASC OS 20/20 RXM PLANO 20/20.

    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 56 YR Other