BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2 LASER

    MDR report key: 2208730 · Received August 3, 2011

    Report

    Report Number
    3006695864-2011-00071
    Event Type
    Injury
    Date Received
    August 3, 2011
    Date of Event
    June 24, 2011
    Report Date
    July 5, 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), EVALUATION: EQUIPMENT WAS SERVICED AND PREVENTIVE MAINTENANCE WAS DONE ON (B)(4) 2011, AFTER THE REPORTED EVENT. NO PROBLEMS WERE FOUND AND SYS MEETS ALL AMO SPECS. NOTE: AT THE DATE OF THIS REPORT AMO HAS PROVIDED ALL AVAILABLE INFO. NO FURTHER INFO IS AVAILABLE OR EXPECTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT PT HAD CONFLUENT GRADE II DLK OD IN EARLY POST OP PERIOD. FLAP LIFTED. BED AND FLAP GENTLY CLEANED WITH MEROCEL SPONGE. PRED FORTE GTTS APPLIED. FLAP REPOSITIONED AND SMOOTHED. NO COMPLICATIONS. SLE PRE LIFT - SLIGHT EDEMA, CLEAR INTERFACE, SMOOTH EDGES, FAINT OPACIFIED AREA CENTRALLY, NO ABRASION, NO BCL, NO PAIN 20/40 UCVA OD. MEDS - DOXYCYCLINE PO 100 MG BID 2 WEEKS, PF 1% Q HR X 1 WEEK, ZYMAXID QID X 4 DAYS, VIT C 1000 MG. LAST PO (B)(6) 2011 FROM AFFILIATE - VASC OD 20/50 + .25 - 1.00 X 005 20/40, VASC OS + 0.25 X 180. SLE - CENTRAL OPACIFIED AREA RESOLVING. D/C DOXY CONT STEROID 1 MORE WEEK THEN QID AND TAPER OVER MONTH. RE CHECK 1 MO OR PRN CHANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRALASE FS2 LASER HNO AMO MANUFACTURING USA LLC 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention