BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS CL

    MDR report key: 3834013 · Received May 27, 2014

    Report

    Report Number
    2648035-2014-00268
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    April 8, 2014
    Report Date
    May 6, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P880081
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    USAGE OF DEVICE: INITIAL USE OF DEVICE. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS (AMO) HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    BECAUSE THE LENS REMAINS IMPLANTED AT THE TIME OF THE EMDR SUBMISSION EXPLANT DATE IS NOT APPLICABLE. REASON FOR NON-EVALUATION: AT THE TIME OF THE EMDR SUBMISSION, THE LENS REMAINS IMPLANTED IN THE PATIENT'S EYE. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS (AMO) HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT SHE HAD AN INTRAOCULAR LENS IMPLANTED IN EACH EYE. THE PATIENT STATED THAT THE OUTLINES OF LETTERS ARE VERY FUZZY AND THINGS ARE VERY BRIGHT SINCE THE LENS WAS IMPLANTED. FOLLOW-UP WITH THE PATIENT INDICATED THAT SHE HAS A PRE-EXISTING CONDITION OF DRY EYE. HER SYMPTOMS HAVE DAMPENED HER DAILY ACTIVITIES. THE PATIENT TAKES PREDNISOLONE DROPS NOW FOR THE THIRD WEEK. THE PATIENT IS UNCOMFORTABLE AND IS SEEING HALOS. THE PATIENT VISITED A CLOSER PHYSICIAN WHO INDICATED THAT THERE WAS NO INFECTION. THE PATIENT SAW THE IMPLANT DOCTOR ONE DAY POST OP FOR EACH EYE AND DISCUSSED DOING A YAG PROCEDURE AT THE END OF (B)(6). THE PATIENT IS NOT WORKING AND IS NOT DRIVING. THE PATIENT IS FRUSTRATED THAT THE IMPLANT PHYSICIAN DID NOT SPEND TIME DESCRIBING THE DETAILS OF THE PROCEDURE AND POST OPERATIVE RESULTS. A SEPARATE E-MDR IS BEING SUBMITTED FOR EACH EYE. THIS E-MDR IS BEING SUBMITTED FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310579 TECNIS CL MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS Z9002

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other