BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS LASER

    MDR report key: 2021623 · Received March 10, 2011

    Report

    Report Number
    3006695864-2011-00018
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    February 10, 2011
    Report Date
    March 11, 2011
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INTERVENTION FLAP REMOVED. EVALUATION: A FIELD SERVICE ENGINEER (FSE) VISITED THE SITE, UPON HIS ARRIVAL, FSE FOUND THE LASER Z STEPPER DRIVER WAS OUT OF SPECIFICATION. FSE CALIBRATED THE Z STEPPER DRIVER TO RESOLVE FLAP THICKNESS AND REPLACED THE SEMI-CONDUCTOR SATURABLE ABSORBER MIRROR (SESAM). FSE PROACTIVELY REPLACED COMPUTER AND LCS TO ANALOG PCB CABLE. MEETS AMO SPECIFICATIONS. A CLINICAL DEVELOPMENT MANAGER (CDM) VISITED THE SITE AND SURGEON REPORTED THAT DURING SURGERY, THE PATIENT'S EYE WAS COMPLETELY NORMAL, DOCKING SMOOTH, MENISCUS EXPOSURE IDEAL AND NO LOSS OF SUCTION OR GAS ESCAPE. CDM REPORTED ON (B)(6) 2011, PRE-OP BCVA IS 20/20 WITH MANIFESTO REFRACTION (MR) -1.75. PATIENT LAST POST-OP VISIT THIS WEEK WAS 20/25 UCVA, 20/20 BCVA WITH MR+0.25 SPHERE. DOCTOR PLANS TO PERFORM PHOTOREFRACTIVE KERATECTOMY (PRK) ON THE PATIENT'S OS IN NEAR FUTURE. CDM PROVIDED SURGERY SUPPORT WITH DOCTOR ON (B)(6) 2011 AND SUCCESSFULLY TREATED 7 EYES ON THE INTRALASE.

    Description of Event or Problem · 1

    THE INTRALASE FS LASER WAS USED TO CREATE BILATERAL CORNEAL FLAPS FOR LASIK SURGERY ON (B)(6) 2011. THE DOCTOR REPORTED TO THE AMO (B)(4) THE LASER CREATED A THIN FLAP OF EPITHELIUM AND THE CONTAINED LITTLE STROMA ON THE PATIENT'S LEFT EYE (OS). ACCOUNT REPORTED THE FLAP THICKNESS WAS 55-60UM, ALMOST ALL EPITHELIUM WITH SOME STROMA TISSUE TEMPORALLY AND THE PROGRAMMED FLAP DEPTH WAS 110UM. SURGEON REMOVED THE EPITHELIAL FLAP, APPLIED MITOMYCIN-C AND INSERTED A BANDAGE CONTACT LENS (BCL). NO EXCIMER TREATMENT PERFORMED. THE PATIENT'S PREOP BCVA WAS 20/20 AND POSTOP BCVA ONE (1) WEEK WAS 20/40.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRALASE FS LASER HNO AMO MANUFACTURING USA, LLC 20003

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R