BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 2955755 · Received February 11, 2013

    Report

    Report Number
    3006695864-2013-00035
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    June 16, 2012
    Report Date
    January 14, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM - BCVA ON (B)(6) 2012, WAS 20/20 OD AND 20/20 OS. CONCLUSION: - THE EQUIPMENT WAS NOT EVALUATED AFTER THE TREATMENT DATE WHICH OCCURRED ON (B)(6) 2012, DUE TO THE FACT ABBOTT MEDICAL OPTICS (AMO) BECAME AWARE ON (B)(4) 2013. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION - THE EQUIPMENT WAS NOT EVALUATED AFTER THE TREATMENT DATE WHICH OCCURRED ON (B)(6) 2012 DUE TO THE FACT ABBOTT MEDICAL OPTICS (AMO) BECAME AWARE ON 01/14/2013. THE CONDITION OF THE SYSTEM (SINCE THE TIME OF THE EVENT) WILL MAKE THE EVALUATION IMPOSSIBLE. THE CLINIC REPORTED THIS EVENT ONLY AND DID NOT REQUEST FIELD SERVICE OR CLINICAL SUPPORT. PHYSICIAN INDICATED THAT THEY DO NOT BELIEVE THE EPITHELIAL ABRASION WAS DUE TO ANY DEVICE. NOTE: ALL PERTINENT INFORMATION AVAILABLE TO AMO AT THE TIME OF THIS REPORT HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH A CORNEAL ABRASION LEFT EYE (OS) AT THE ONE DAY POST-OP ON (B)(6) 2012. BANDAGE CONTACT LENS WAS PLACED OS. STAGE 2 DIFFUSE LAMELLAR KERATITIS (DLK) PRESENTED 5 DAYS LATER AND A TOPICAL STEROID WAS USED. EPITHELIAL INGROWTH WAS OBSERVED SO A LIFT WAS PERFORMED ON (B)(6) 2012. PATIENT HAD ANOTHER MILD EROSION POST-OP THAT WAS TREATED AND HEALED. PATIENT WAS RELEASED FROM CUSTOMER''S CARE ON (B)(6) 2012. PRE-OP BEST CORRECTED VISUAL ACUITY (BCVA) WAS 20/20. PATIENT DID NOT EXPERIENCE LOSS OF BCVA. UNCORRECTED VISUAL ACUITY (UCVA) ON (B)(6) 2012 WAS 20/30 ON THE RIGHT EYE (OD) AND 20/20 (OS). BCVA ON (B)(6) 2012 WAS 20 OD AND 20/20 OS. THE DLK WAS RESOLVED. SURGEON INDICATED THAT THERE IS A WELL ENCAPSULATED EPITHELIAL NEST THAT SURGICALLY THERE WAS NO INDICATION TO TREAT AT THIS POINT. PATIENT SEEMED CONTENT WITH OVERALL VISION AND OUTCOME. PATIENT RECEIVED ABRASION AFTER TREATMENT AND WAS NOT DUE TO ANY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58352 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20005D

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other| R