BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1-PIECE

    MDR report key: 3813486 · Received May 15, 2014

    Report

    Report Number
    2648035-2014-00243
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 8, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT OR DATE OF BIRTH: REQUESTED; HOWEVER, UNKNOWN. SEX - REQUESTED; HOWEVER, UNKNOWN. SECTION F HAS BEEN COMPLETED BY THE MANUFACTURER. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS AHS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K) #: (B)(4). USAGE OF DEVICE: INITIAL USE OF DEVICE. ADDITIONAL INFO: THE MANUFACTURING RECORDS WERE REVIEWED AND ALL TESTS RESULTS SHOWED A PASS CONDITION. NO DEVIATION OR NON-CONFORMANCE (NCR) RELATED TO THE CUSTOMER CLAIM WAS GENERATED. THE LENS MET ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE LENS WAS IMPLANTED, THE DOCTOR NOTICED A TEAR IN THE CAPSULAR BAG. THE DOCTOR REMOVED THE LENS IN TWO PIECES AND PERFORMED A VITRECTOMY. THE DOCTOR THEN IMPLANTED A ZA9003 LENS SUCCESSFULLY WITHIN THE SAME PROCEDURE. IN ADDITION, IT WAS REPORTED THAT THE INCISION WAS ENLARGED AND THAT THE EYE WAS SUTURED AFTER THE NEW LENS WAS IMPLANTED. NO ADVERSE EFFECT AND NO PATIENT INJURY WERE REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290035 TECNIS 1-PIECE MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CARTRIDGE MODEL 1MTEC30, LOT NO. CP00270