BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR

    MDR report key: 4670334 · Received April 8, 2015

    Report

    Report Number
    3006695864-2015-00113
    Event Type
    Injury
    Date Received
    April 8, 2015
    Report Date
    March 9, 2015
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    LZS
    PMA / PMN Number
    P930016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CLINIC IS REPORTING THIS ADVERSE EVENT ONLY AND DID NOT REQUEST OR REQUIRE FIELD SERVICE. INFORMATION WAS DISCUSSED WITH THE ACCOUNT AND THE FOLLOWING WAS RECOMMENDED TO THE SURGEON: USE AN INSTRUMENT DETERGENT WITH DISTILLED WATER AS OPPOSED TO CLEANING HIS INSTRUMENTS WITH TAP WATER. EMPTY RESERVOIR IN STERILIZER NIGHTLY. STOP USING TALC FREE GLOVES. USE NON-FRAGMENTING LASIK SPONGE. MORE AGGRESSIVE USE OF TOPICAL STEROIDS WHEN THE DIAGNOSIS OF DLK IS MADE. CONSIDER USING DIFFERENT MICROKERATOME (CURRENTLY USING MORIA ONE USE). THERE IS NO EVIDENCE TO SUGGEST THE ETIOLOGY OF THE DLK IS RELATED TO THE S4 IR LASER SYSTEM. DEVICE MANUFACTURE DATE: UNKNOWN, ASKED BUT NOT AVAILABLE AT THE TIME OF THIS REPORTING. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD TRACE DIFFUSE LAMELLAR KERATITIS (DLK) FOLLOWING LASER CORRECTION SURGERY. ADDITIONALLY, THE PATIENT AT THE MOST RECENT FOLLOW UP VISIT, WAS NOTED TO HAVE A LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA) OF TWO (2) OR MORE LINES FROM THE DAY ONE POST OP VISIT. PATIENT HAD VERTICAL IRREGULARITY TEMPORAL TO VISUAL AXIS. DATE OF SURGERY: (DOS) (B)(6) 2014 POST ¿ OPERATIVE INFORMATION: 1 DAY OD: TRACE DIFFUSE LAMELLAR KERATITIS (DLK) INFERIORLY; 1+ PUNCTATE EPITHELIAL KERATITIS (PEK) OS: 1+ PEK VISUAL ACUITY (VA): OD: 20/25-1 OS: 20/15-1 6 DAYS VISUAL ACUITY: OD: 20/20-2 OS: 20/20+ 1 MONTH 4 DAYS VISUAL ACUITY: OD: 20/25- OS: 20/20 5 MONTHS 7 DAYS VISUAL ACUITY: OD: 20/30+2 OS: 20/20- 6 MONTHS 8 DAYS OS: VERTICAL IRREGULARITY TEMPORAL TO VISUAL AXIS VISUAL ACUITY: OD: 20/40 OS: 20/25-

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231911 STAR EXCIMER LASER LZS ABBOTT MEDICAL OPTICS 0030-1479

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other