BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2 LASER

    MDR report key: 2158503 · Received July 5, 2011

    Report

    Report Number
    3006695864-2011-00063
    Event Type
    Injury
    Date Received
    July 5, 2011
    Date of Event
    May 23, 2011
    Report Date
    June 3, 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). REQUESTED FOLLOW UP FROM PATIENT AND ACCOUNT REPORTED THE FOLLOWING: (B)(6) 2011 - VASC 20/60 OU; RXM OD -1.00 SPHERE 20/25-1; OS -.25 -.75 X 178 20/20-1 OS; IOP 10/11 MMHG; SLE: OD. QUIET A/C. CORNEA: AREA OF HAZE OVER INFILTRATE SCAR, NO STAINING. TRACE SPK WITH TRACE INJECTION AT LIMBUS. SLE OS - FLAP IN PLACE AND CLEAR, A/C DEEP AND QUIET. MEDS: PRED FORTE QID OD AND PF AFT'S EVERY HOUR. (B)(4) EPITHELIAL INFILTRATE, SPK, HAZE OVER INFILTRATE SCAR. AT THE TIME OF THIS REPORT EQUIPMENT EVALUATION HAS NOT BEEN COMPLETED. WHEN THE EQUIPMENT EVALUATION IS COMPLETED A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION, CONCLUSION: AT THE TIME OF THIS REPORT EQUIPMENT EVALUATION HAS NOT BEEN COMPLETED. WHEN THE EQUIPMENT EVALUATION IS COMPLETED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    PATIENT UNDERWENT UNCOMPLICATED LASIK ON (B)(6) 2011. SHE WAS FOLLOWED BY HER CO-MANAGING DOCTOR ON (B)(6) 2011. HER DOCTOR DIAGNOSED AN INFILTRATE OD AND REFERRED THE PATIENT TO THE (B)(6). PATIENT WAS STARTED ON VANCOMYCIN EVERY 30 MINUTES, ZYMAXID EVERY HOUR AND BACITRACIN/POLYTRIM OINTMENT OVERNIGHT. FOLLOW-UP NEXT MORNING. CULTURE WAS NEGATIVE. ON (B)(6) 2011 POST OP UCVA 20/70 OD, 20/60 OS. PH - 20/30 OD, 20/30 OS. OD SLE - AREA OF EDEMA WITH PINPOINT STAINING AT LOCATION OF HEALING INFILTRATE. CONTINUING VANCO, POLYTRIM AND ZYMAXID - RE-CHECK IN 5 DAYS.

    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 39 YR Required Intervention