BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 3230178 · Received July 16, 2013

    Report

    Report Number
    2648035-2013-00289
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    June 28, 2013
    Report Date
    July 3, 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

    THE INTRAOCULAR LENS (IOL) WAS RETURNED TO OUR QUALITY ASSURANCE LABORATORY FOR INSPECTION. A VISUAL INSPECTION OF THE RETURNED LENS NOTED ONE (1) DISTORTED HAPTIC AND APPEARED TO HAVE EVIDENCE OF DEBRIS/PARTICLES AND VISCOELASTIC. NO FURTHER INSPECTION OF THE LENS WAS POSSIBLE DUE TO THE CONDITION OF THE RETURNED LENS.

    Additional Manufacturer Narrative · 1

    (B)(4) USED FOR INCISION ENLARGED. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT THAT AN INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE. THE REPORT INDICATED THAT THE PATIENT DID NOT HAVE A POSTERIOR CAPSULE AND REQUIRED AN ANTERIOR CHAMBER LENS. THE INCISION WAS ENLARGED TO REMOVE THE LENS AND A VITRECTOMY PERFORMED. PATIENT IS REPORTED TO BE DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328537 TECNIS MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZA9003

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention