BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFS

    MDR report key: 4970718 · Received August 5, 2015

    Report

    Report Number
    3006695864-2015-00485
    Event Type
    Injury
    Date Received
    August 5, 2015
    Date of Event
    June 26, 2015
    Report Date
    July 8, 2015
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    APPLICATION SUPPORT MANAGER (ASM) VISITED SITE TO CHECK INTRALASE AND GATHER INFORMATION FROM THE SITE REGARDING DLK PATIENTS AND ROOM ENVIRONMENT. DURING SYSTEM CHECK, ACHIEVED >65 PERCENT MELT IN GEL WITH SURGICAL ENERGY OF .80, 7/7 SPOT/LINE. DURING Z-CAL, THE AVERAGE FLAP IN GEL WAS 127 MICRONS FOR A 120 MICRON PROGRAMMED DEPTH. SITE STATES THAT THEY HAVE NOT CHANGED THEIR ROUTINE FOR GLOVES OR CLEANING SUPPLIES. THEY USE THE STATIM CASSETTE AUTOCLAVE AND MENTIONED THAT THEY CHANGE THE GASKET EVERY OCTOBER. THEY CLAIM THAT SPORE-TESTING SHOWS NEGATIVE. RECOMMENDED THAT THEY STOP USING (B)(6) GLOVES, CHANGE THE GASKET AND CALL THE AUTOCLAVE MANUFACTURING COMPANY AND HAVE IT CHECKED AND POSSIBLY SERVICED. EQUIPMENT LABELING PROVIDES POTENTIAL ADVERSE EFFECTS THAT CAN BE CAUSED BY THE SURGICAL/TREATMENT PROCEDURE BEING PERFORMED. THE OPERATOR MANUALS FOR THE VARIOUS EQUIPMENT WERE REVIEWED AND DETERMINED TO INCLUDE ADEQUATE WARNINGS FOR MEDICAL COMPLICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    ACCOUNT REPORTED PATIENT PRESENTED WITH DIFFUSE LAMELLAR KERATITIS (DLK) STAGE II IN LEFT EYE POST TREATMENT. DATE OF SURGERY (B)(6) 2015 AND WAS USED AS DATE OF EVENT AS BEST ESTIMATE. IT WAS REPORTED THAT PATIENT IS RESPONDING TO TOPICAL STEROIDS AND BANDAGE CONTACT LENS WAS USED. NO POST TREATMENT EPI-DEFECT WAS PRESENT. NO LOSS OF BEST CORRECTED VISUAL ACUITY REPORTED AND DLK WAS NOT RESOLVED BY (B)(6) 2015. PATIENT WAS CURRENTLY USING PREDNISOLONE ACETATE 2 TIMES A DAY IN LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513511 IFS FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS J20007D

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention