BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFS

    MDR report key: 6146796 · Received December 5, 2016

    Report

    Report Number
    3006695864-2016-00972
    Event Type
    Injury
    Date Received
    December 5, 2016
    Date of Event
    August 29, 2016
    Report Date
    December 5, 2016
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    UDI-DI
    05050474573468
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CLINIC IS REPORTING THIS ADVERSE EVENT ONLY AND DID NOT REQUEST OR REQUIRE FIELD SERVICE OR CLINICAL SUPPORT. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    ACCOUNT REPORTED SURGEON USED INTRALASE FEMTOSECOND LASER TO CREATE INCISION TO INSERT KAMRA INLAY LENS IN PATIENTS RIGHT EYE ON (B)(6) 2016. PATIENT PRESENTED WITH CORNEAL MELT AND INFECTION POST OP AND THE INLAY WAS REMOVED ON (B)(6) 2016. BEST CORRECTED VISUAL ACUITY (BCVA) (B)(6) 2016: 20/16; UNCORRECTED VISUAL ACUITY (UCVA) (B)(6) 2016: FINGER COUNTING NO BCVA OBTAINED POST OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797285 IFS FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS J20007D 05050474573468

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention KAMRA INLAY UNKNOWN SERIAL#