BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 3803316 · Received May 9, 2014

    Report

    Report Number
    2648035-2014-00222
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    March 13, 2014
    Report Date
    April 16, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P990080
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS (IOL) WAS RETURNED TO THE MANUFACTURER. THE LENS WAS RECEIVED FOR VISUAL EXAMINATION. NO DAMAGES WERE OBSERVED. THE LENS WAS ALSO INSPECTED AT 10X MICROSCOPE MAGNIFICATION NO COSMETIC DEFECT SUCH AS SCRATCHES OR DEPRESSION MARKS WAS DETECTED. SMALL RESIDUE OF VISCOELASTIC (OVD) OBSERVED ON THE LEADING HAPTIC AND LENS EDGE. ALSO, LOOSE PARTICLES WERE OBSERVED ON THE LENS OPTIC BODY COMPATIBLE WITH HANDLING THE LENS OUT OF THE STERILE ENVIRONMENT. THE SAMPLE WAS OBSERVED WITH THE CHARACTERISTIC ACRYLIC 3-PIECE LENS. DIOPTER MEASUREMENT WAS PERFORMED BY A CERTIFIED OPERATOR ACCORDING TO THE OPTICAL SPECIFICATIONS. LENS PASSED THE OPTICAL PROPERTIES. NO DEVIATION WAS DETECTED IN THE COMPLAINT LENS. THE DIOPTER RESULT WAS 20.5 AS REPORTED IN THE INITIAL REPORT. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO DEVIATIONS OR NONCONFORMITIES. THE DOCUMENTATION SHOWED THAT THE PRODUCTION ORDER WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS AT THE TIME OF THIS REPORT HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS REQUIRED TO BE EXPLANTED FROM THE LEFT EYE OF A PATIENT IN A SECONDARY PROCEDURE OWING TO DYSPHOTOPSIA. A NEW LENS WAS IMPLANTED IN THE EYE. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280588 TECNIS MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZA9003

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention