BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 2933715 · Received January 29, 2013

    Report

    Report Number
    2648035-2013-00064
    Event Type
    Injury
    Date Received
    January 29, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 16, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P990080
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRIOR TO RELEASE TO MARKET, THE INTRAOCULAR LENS MET ALL MANUFACTURING SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE EXPLANTED INTRAOCULAR LENS WAS RETURNED TO ABBOTT MEDICAL OPTICS QUALITY ASSURANCE LABORATORY. THE INSPECTION OF LENS NOTED ONE (1) DISTORTED HAPTIC, WITH EVIDENCE OF BLOOD AND VISCOELASTIC. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CAPSULAR TEAR WAS PRESENT WHILE THE INTRAOCULAR LENS WAS BEING IMPLANTED INTO THE CAPSULAR BAG. IT WAS STATED THAT THE CAPSULAR TEAR WAS ATTRIBUTED TO PATIENT PATHOLOGY. HOWEVER, THE LENS WAS IN THE CAPSULAR BAG DURING THE TEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39253 TECNIS MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZA9003

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention