BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 3130558 · Received May 24, 2013

    Report

    Report Number
    3006695864-2013-00180
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    March 20, 2013
    Report Date
    April 15, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - (MEIBOMIAN GLAND SECRETIONS). EVALUATION CONCLUSION - THE EQUIPMENT WAS NOT EVALUATED AFTER THE TREATMENT DATE WHICH OCCURRED ON (B)(6) 2013 DUE TO THE FACT ABBOTT MEDICAL OPTICS (AMO) BECAME AWARE ON (B)(6) 2013. THE CONDITION OF THE SYSTEM (SINCE THE TIME OF THE INITIAL PROCEDURE) WILL MAKE THE EVALUATION DIFFICULT. CUSTOMER IS ONLY REPORTING THIS EVENT AND DID NOT REQUEST FIELD SERVICE OR CLINICAL SUPPORT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: ORIGINAL LASIK SURGERY WAS ON (B)(6) 2013. THE FLAP LIFT AND RINSE WAS DONE ON THE 1-WEEK POST-OP, WHICH WAS ON (B)(6) 2013.

    Description of Event or Problem · 1

    CUSTOMER REPORTED SECRETIONS AND SLIGHT FUZZINESS ON PATIENT'S EYE. FURTHER FOLLOW-UP WAS OBTAINED. THE SECRETIONS IRRIGATED WERE PRESENT IN THE INTERFACE DUE TO THE NORMAL MEIBOMIAN GLAND SECRETIONS FOUND ON THE PATIENT'S CONJUNCTIVA, WHICH OCCASIONALLY GET TRAPPED IN THE FLAP INTERFACE DURING THE NORMAL IRRIGATION OF THE INTERFACE DURING LASIK. THE PATIENT WAS TREATED WITH TOPICAL STEROIDS AS PER ROUTINE DURING HIS FIRST POSTOPERATIVE WEEK. THERE WAS NO SIGN OF INFLAMMATION NOR OF INFECTION. BUT SINCE HE COMPLAINED OF FUZZINESS DESPITE 20/20 VISION, AND THE SECRETIONS WERE NOTED ON HIS 1 WEEK POST-OP EXAM, A FLAP LIFT AND RINSE WERE PERFORMED ON THAT DAY. HIS "FUZZINESS" ENTIRELY RESOLVED AND VISION WAS 20/15 BY THE FIRST DAY AFTER THE RINSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231446 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20005D

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other| R