BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 19945857 · Received August 8, 2024

    Report

    Report Number
    3012236936-2024-000215
    Event Type
    Injury
    Date Received
    August 8, 2024
    Date of Event
    June 27, 2024
    Report Date
    August 8, 2024
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474810716
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2, A3B, A4 WEIGHT OF PATIENT: UNKNOWN/ ASKED BUT NOT AVAILABLE. SECTION E1:SURGEON'S EMAIL ADDRESS AND PHONE NUMBER: UNKNOWN/ ASKED BUT NOT AVAILABLE. SECTION H3: OTHER 81: THE DEVICE WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT HAD CATARACT SURGERY AND POST TREATMENT WAS UNHAPPY WITH THE SHARPNESS AND QUALITY OF HER DISTANCE VISION AND FELT UNABLE TO SEE FINE PRINT FROM 60-30CM. PATIENT REPORTED POST-OP LONGSTANDING HISTORY OF DRY EYE ISSUES DESPITE NO PRE-OP DOCUMENTATION OF IT AND EXCELLENT PRE-OP ITRACE ABERROMETRY ANALYSIS. THERE WAS NO ISSUE WITH THE LENS AND NO USE ERROR. LENS WAS EXPLANTED. THE PATIENT WAS TEMPORARILY IMPAIRED. THE BSCVA PRE-OP WAS: 20/40 AND THE BSCVA POST-OP WAS: 20/30 AFTER THE ODYSSEY EXPLANT, A MONOFOCAL LENS WAS USED. POST MONOFOCAL IMPLANTATION THERE WAS SIGNIFICANT IMPROVEMENT IN THE PATIENT¿S PERCEPTION IN THE QUALITY OF VISION AT DISTANCE. PATIENT IS AN AVID FLY FISHERWOMAN AND WAS UNABLE TO TIE FLY FISHING LURES WITH THE ORIGINAL ODYSSEY IOL LENS BUT IS VERY PLEASED WITH THE IOL EXCHANGE AND CATCHING LOTS OF FISH ON HER FISHING TRIP; USES OVER THE COUNTER READERS TO TIE HER FISHING LURES. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1646712 TECNIS SIMPLICITY LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DRN00V 05050474810716

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention