BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2 LASER

    MDR report key: 2223100 · Received August 15, 2011

    Report

    Report Number
    3006695864-2011-00076
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 19, 2011
    Manufacturer
    AMO MANUFACTURING USA, LLC.
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EPITHELIAL INGROWTH. EVAL: FIELD SERVICE SPECIALIST (FSS) CHECKED SYSTEM AFTER THE REPORTED EVENT ON (B)(4) 2011 AND PREVENTIVE MAINTENANCE WAS PERFORMED ON LASER. SYSTEM MEETS AMO SPECIFICATIONS.

    Description of Event or Problem · 1

    PRE OP - (B)(6) 2011. VSC OD 20/100 OS 20/100. VCC OD 20/30 OS 20/25. (B)(6) OD 44.25/42.87 X 088 OS 44.12/43/12X085. MAN OD -1.75 -1.75X088 OS -1.00 -1.50X095 20/20. PACH OD 618 OS 614 (ORBSCANS). CR OD 1.25 -1.75X090 OS -1.00 -1.75X087 (B)(6). ON (B)(6) 2011, 1 DAY PO LASIK OU VSC OD 20/80 OS 20/25. FLAP HAS SLIPPED OD. SEE SURGEON THIS AFTERNOON/REFERRING DOCTOR / (B)(6) 2011 CAME IN TO (B)(6). VA BLURRY OUT OD. OS VA IS GOOD. VA OD 20/100 OS 20/20. ON (B)(6) 2011, PF AND ZYMAXID QID OU. HAS NOT USED OUT TEARS YET. ON (B)(6) 2011, REFLOAT AND REPOSITION FLAP OD. OP NOTES, SLIPPED FLAP OD. REPOSITIONED FLAP OD - BETADINE PREP, GLOVED, DRAPE - LIFT FLAP WITH SYNSKEY. REMOVED EPI FROM BED WITH TOOKE. REMOVED EPI FROM FLAP WITH SPONGE. REPLACE AND STRETCHED FLAP. BCTL. ZYMAXID, AP F/U WITH HER DR (B)(6) 2011.

    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 68 YR Required Intervention