BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE

    MDR report key: 7201094 · Received January 17, 2018

    Report

    Report Number
    2648035-2018-00131
    Event Type
    Injury
    Date Received
    January 17, 2018
    Date of Event
    December 15, 2017
    Report Date
    January 17, 2018
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE LOT NUMBER IS UNKNOWN AS IT WAS NOT PROVIDED. DEVICE EXPIRATION DATE IS UNKNOWN AS LOT NUMBER WAS NOT PROVIDED. UNIQUE IDENTIFIER IS UNKNOWN AS LOT NUMBER WAS NOT PROVIDED. (B)(4). LABEL COPY STATES CORNEAL FIXATION VACUUM LOSS CAN OCCUR. THERE ARE SEVERAL FACTORS THAT MAY CONTRIBUTE TO SUCTION ISSUES SUCH AS DOCTOR'S TECHNIQUE IN APPLYING THE SUCTION RING TO THE CORNEA, DOCTOR'S TECHNIQUE IN SQUEEZING THE PI CLIP TO SECURE THE SUCTION RING TO THE PI CONE AND PATIENT ANATOMY AFFECTING THE INTERFACE BETWEEN THE PATIENT'S CORNEA AND THE SUCTION RING. DEVICE MANUFACTURER DATE IS UNKNOWN AS LOT NO WAS NOT PROVIDED. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING PROCEDURE AND WHILE LASER WAS FIRING A SUCTION BREAK OCCURRED. SURGEON WAS ABLE TO CONTINUED AND COMPLETED THE RASTER FIRING. WHEN FLAP WAS DONE SURGEON CONFIRMED THERE WAS AN INCOMPLETE SIDE CUT. SURGEON DECIDED TO USE A KNIFE AND SCISSORS TO OPEN THE SIDE CUT. DURING THIS PROCESS THE FLAP TORE (A LITTLE). IT WAS REPORTED SURGEON EVALUATED THE (RASTER) BED-SIDE AND FOUND NO PROBLEM AND THEREFORE THE EXCIMER LASER FIRING WAS IMPLEMENTED AND FINISHED. ACCORDING TO THE SURGEON, THERE WAS A LITTLE EPITHELIAL DEFECT AT ONE DAY AFTER OPERATION. HOWEVER, IT HAS ALREADY RECOVERED WITHOUT TREATMENT AND PATIENT HAD GOOD EYE SIGHT (GOOD OUTCOME). BEFORE OPERATION: LV F0.03 I1.5 S -8.25 DC -0.5 DA X 170. IDESIGN TOTALCORRECTION: LV FS -9.04 DC -0.47 DA X 7. ONE (1) DAY POST OPERATION: LV F1.2 I1.5 S -0.25 DC-0.5 DA X 180.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46030 INTRALASE PATIENT INTERFACE HNO ABBOTT MEDICAL OPTICS 590106AN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other INTRALASE UNKNOWN SERIAL