BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1-PIECE

    MDR report key: 4864003 · Received June 23, 2015

    Report

    Report Number
    2648035-2015-00384
    Event Type
    Injury
    Date Received
    June 23, 2015
    Date of Event
    May 6, 2015
    Report Date
    August 26, 2015
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UDI #: (B)(4). THE INTRAOCULAR LENS (IOL) WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. ONE OF THE HAPTICS WAS OBSERVED COMPLETE AND WITH NO VISIBLE DEFECT. THE OTHER HAPTIC WAS SEVERED AND WAS NOT RETURNED. THE SAMPLE HAD RESIDUALS (DEBRIS/PARTICLES). RESIDUE OF WHAT APPEARED TO BE HARDENED VISCOELASTIC WAS OBSERVED. THE LENS CONDITION IS CONSISTENT WITH A LENS THAT WAS EXPLANTED FROM THE PATIENT'S EYE. THE MANUFACTURING RECORD REVIEW WAS PERFORMED. ALL PROCESS OPERATIONS PRESENTED IN THE MANUFACTURING RECORD FROM PRODUCT GENERATION TO PRODUCT BOXING WERE IN COMPLIANCE WITH MANUFACTURING INSTRUCTION SPECIFICATIONS. ALL TEST RESULTS SHOWED A PASS CONDITION. THE LENS DIOPTER MEASUREMENT RESULTS INDICATE THAT IT WAS WITHIN SPECIFICATION DURING THE MANUFACTURING PROCESS. THE DOCUMENTATION SHOWED THAT THE PRODUCTION ORDER WAS FOUND TO BE WITHIN SPECIFICATIONS AND THE DEVICE MET MANUFACTURING RELEASE CRITERIA. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED AN EXPLANT, OF A TECNIS 1-PIECE INTRAOCULAR LENS (IOL), FROM THE PATIENT'S RIGHT EYE DUE TO IMPAIRED VISION AND DYSPHOTOPSIA. A SEPARATE MDR IS BEING FILED FOR THE EXPLANT FROM THE PATIENT'S LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404762 TECNIS 1-PIECE MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention