BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS3 LASER

    MDR report key: 2071931 · Received April 21, 2011

    Report

    Report Number
    3006695864-2011-00031
    Event Type
    Injury
    Date Received
    April 21, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 22, 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). INFILTRATES, DIFFUSE LAMELLAR KERATITIS-STAGE UNK. EVAL: AT THE TIME OF THIS REPORT EQUIPMENT EVAL HAS NOT BEEN COMPLETED. WHEN THE EQUIPMENT EVAL IS COMPLETED A SUPPLEMENTAL WILL BE SUBMITTED. NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT WAS EXAMINED PRE-OP AND HAD NOTED ON HISTORY THAT HE WAS A (B)(6) CARRIER. DOCTOR RECOMMENDED ZYMAXID PLUS POLYTRIM PRE-OP SURGERY. PT AGREED AND WAS GIVEN BOTH PRESCRIPTIONS. SURGERY COMPLETED W/O INCIDENT. PT HAD CUSTOM INTRALASE OU. ON (B)(6) 2011, DR SAW PT AT 1 DAY - NO PROBLEMS NOTED. ON (B)(6) 2011, DR SAW PT IN AM - SENT PT TO (B)(6). ON (B)(6) 2011, PT SEEN AT (B)(6) - DR NOTED INFILTRATE OU - CONTINUE POLYTRIM- CONT. ZYMAXID QID OU ADDED (B)(4)-QID-OU. BEGAN VANCOMYCIN-GLH-OU- PT WILL RETURN TO CLINIC TOMORROW. ON (B)(6) 2011, PT RETURNED FOR F/U VASC 20/20 OD, 20/30 OS INFILTRATES OU WITH SPK (SUPERFICIAL PUNCTATE KERATITIS) AND DLK (DIFFUSE LAMELLAR KERATITIS) OS. CONTINUE ON MEDS, CULTURE RESULTS NOT AVAILABLE YET. RE-CHECK TOMORROW.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other