BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FEMTOSECOND LASER

    MDR report key: 2011723 · Received March 4, 2011

    Report

    Report Number
    3006695864-2011-00014
    Event Type
    Injury
    Date Received
    March 4, 2011
    Report Date
    March 4, 2011
    Manufacturer
    AMO MANUFACTURING USA LLC
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ARTICLE CITATION: NIKOLAOS S TSIKLIS; ACTA OPHTHALMOLOGICA 2011 (2011: 89: 54-57) ABSTRACT & RESULTS. (B)(4) CORNEAL MELTING, ADD'L INTERVENTION-SUTURES REQUIRED. NO INFO AT THE TIME. EQUIPMENT HAS NOT BEEN IDENTIFIED. INVESTIGATION IS BEING CONDUCTED TO IDENTIFY THE EQUIPMENT.

    Description of Event or Problem · 1

    ON (B)(6) 2011, COPY OF ACTA OPHTHALMOLOGICA 2011: 89: 54-57 WAS RECEIVED AND SURGEON REPORTED COMPLICATIONS OF INTRASTROMAL CORNEAL RING SEGMENT IMPLANTATION USING A FEMTOSECOND LASER FOR CHANNEL CREATION. A TOTAL OF 49 CASES OUT OF 850 EYES (531 PATIENTS). NO PT IDENTIFIERS AVAILABLE. THE REPORTED COMPLICATIONS (CASES) ARE: 22 INCOMPLETE FLAP CREATION-ALL CHANNELS WERE COMPLETED USING MECHANICAL SEPARATOR. FIVE GALVO LAG ERROR-ALL CASES THE ERROR OCCURRED 2 SECONDS BEFORE THE COMPLETION OF THE INCISION. TWO PTS, PROCEDURE RESTARTED AND ERROR OCCURRED AGAIN AT SAME TIME AND 30-DEGREE KNIFE USED TO COMPLETE THE INCISION. THREE PTS, NO INFO REPORTED. FIVE ENDOTHELIAL PERFORATION- TWO PTS, RING WAS DISPLACED INITIALLY, MOVING TO ANTERIOR CHAMBER. THREE PTS, ENDOTHELIAL PERFORATION WAS RECOGNIZED DURING 2 INCORRECT ENTRY OF THE CHANNEL OCCURRED WHILE USING THE 150UM RING AND A MECHANICAL SEPARATOR WAS USED TO CREATE A SECOND CHANNEL. ONE VACUUM LOSS (SUCTION LOSS) - VACUUM CREATED AGAIN AND CHANNEL CREATED SUCCESSFULLY. ELEVEN SEGMENT MIGRATION - 7 PTS, SEGMENTS MIGRATED IN THE CHANNEL; SUTURE PLACED AT THE INCISION AND REMOVED 2 MONTHS LATER. FOUR PTS, SUPERFICIAL MOVEMENT OF THE SEGMENTS AND ALL SEGMENTS REMOVED BEFORE CORNEAL MELTING. TWO CORNEAL MELTING-NOTICED ABOVE SEGMENTS BECAUSE OF THE SUPERFICIAL PLACEMENT OF THE RINGS; SEGMENT EXPLANTATION DONE WITH NO FURTHER INCIDENCES. ONE MILD INFECTION-PATIENT EXPERIENCE CORNEAL ABSCESS AT THE INCISION SITE. TREATED WITH INTENSE ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRALASE FEMTOSECOND LASER HNO AMO MANUFACTURING USA LLC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other