BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 3230674 · Received July 16, 2013

    Report

    Report Number
    3006695864-2013-00272
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 29, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLETED BY MANUFACTURER. EVALUATION: AMO'S FIELD SERVICE ENGINEER WAS ONSITE TO TROUBLESHOOT DUE TO REPORT OF DECENTERED FLAP. TROUBLESHOOTING WAS DONE AS REQUIRED FOR FLAP/OVERLAY ALIGNMENT ISSUES. CORRELATION TO X-GALVO ''HISSING'' ESTABLISHED. ISSUES WERE CORRECTED BY RESEATING CABLE CONNECTIONS ASSOCIATED WITH THE GALVO ASSEMBLY. PREVENTATIVE MAINTENANCE (PM) AND FULL SYSTEM VERIFICATIONS PERFORMED. LASER ENGINE OPTIMIZED. FSE PERFORMED GEL TESTING AND COMPLETED STANDARD SERVICE CALL CHECK LIST. INSTRUMENT MEETS AMO SPECIFICATIONS.

    Description of Event or Problem · 1

    PATIENT LEFT EYE FLAP WAS DECENTERED. EYE WAS CONVERTED TO PHOTOREFRACTIVE KERATECTOMY (PRK) AND COMPLETED SUCCESSFULLY. PATIENT UNCORRECTED VISUAL ACUITY AT 2 WEEKS POST OP WAS 20/15. THERE WAS NO LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA), NO FURTHER TREATMENT OR MEDICAL INTERVENTION WAS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329108 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 Other