BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1-PIECE

    MDR report key: 3120858 · Received May 20, 2013

    Report

    Report Number
    2648035-2013-00230
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    December 20, 2012
    Report Date
    May 2, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EXPLANTED INTRAOCULAR LENS WAS RETURNED TO OUR QUALITY ASSURANCE LABORATORY FOR INSPECTION. A VISUAL INSPECTION NOTED THAT THE LENS WAS CUT, TORN, AND APPEARED TO HAVE EVIDENCE OF BLOOD AND VISCOELASTIC. NO FURTHER INSPECTION WAS POSSIBLE DUE TO THE CONDITION OF THE RETURNED/EXPLANTED LENS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A POSTERIOR CAPSULAR TEAR, THAT WAS NOT CAUSED BY INTRAOCULAR LENS (IOL) AND THE LENS REQUIRED REMOVAL. AN IOL CUTTER WAS USED TO CUT LENS OUT. A NEW LENS WAS PLACED IN THE SULCUS. AN INCISION ENLARGEMENT WAS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222039 TECNIS 1-PIECE MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention