BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 2920569 · Received January 17, 2013

    Report

    Report Number
    3006695864-2013-00008
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 18, 2012
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER DID NOT FEEL THE INTRALASE IS THE CAUSE OF THE INFLAMMATION. AMO'S CLINICAL DEVELOPMENT MANAGER (CDM) RECOMMENDATIONS MADE TO THIS ACCOUNT: USE STERILE WATER (INSTEAD OF FILTERED WATER) FOR INSTRUMENT CLEANING, RINSING AND TO FILL STATIM STERILIZER. CLEAN INSTRUMENTS IN FRESH CLEANING WATER AND TWO RINSES (WITH STERILE WATER). CHANGE WATER BETWEEN PATIENTS. EMPTY WASTE BOTTLE AFTER EACH SURGERY DAY, RINSE IT AND REFILL WITH FRESH WATER BEFORE EACH USE. MAY WANT TO TRY SWITCHING TO LATEX FREE GLOVES FOR ALL PATIENTS. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    NOTE: ALL PERTINENT INFORMATION AVAILABLE TO AMO AT THE TIME OF THIS REPORT HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, DOCTOR REPORTED PATIENT WITH TRACE DLK (DIFFUSE LAMELLAR KERATITIS) ON THE LEFT EYE (OS). NO LIFT AND RINSE WAS PERFORMED. PATIENT'S PREDFORTE WAS INCREASED. NO LOSS OF BEST CORRECTED VISUAL ACUITY WAS REPORTED. UNCORRECTED VISUAL ACUITY (UCVA) 20/15 ON RIGHT EYE (OD) AND 20/15 ON LEFT EYE (OS). PATIENT'S DLK HAD RESOLVED BY THE THREE WEEK FOLLOW UP VISIT ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25735 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20005D

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other