BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS CL

    MDR report key: 2832637 · Received November 14, 2012

    Report

    Report Number
    2648035-2012-00359
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 8, 2012
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P880081
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED INTRAOCULAR LENS (IOL) WAS RETURNED TO OUR MANUFACTURING FACILITY FOR EVALUATION. THE EXPLANTED LENS SAMPLE WAS RECEIVED IN TWO HALVES. THE EXPLANTED LENS SAMPLE WAS INSPECTED AT A 10X MICROSCOPIC MAGNIFICATION WHICH IS THE NORMAL INSPECTION METHOD. THE VISUAL INSPECTION REVEALED SURFACE RESIDUALS (FIBERS, PARTICLES AND STAINS)AND UNACCEPTABLE SCRATCHES ON THE LENS SURFACE WHICH WERE COMPATIBLE WITH HANDLING OF THE LENS DURING THE IMPLANT AND EXPLANT PROCESS. NO OTHER UNACCEPTABLE COSMETIC DEFECTS WERE FOUND IN THE RETURNED LENS. AT THE FINAL INSPECTION PROCESS LENSES ARE 100% CLEANED AND INSPECTED AT 10X MICROSCOPE MAGNIFICATION FOR COSMETIC DEFECTS INCLUDING HAPTIC DEFECTS AND SURFACES RESIDUALS. THEREFORE, THE CONDITION OF THE EXPLANTED LENS DID NOT SUGGEST A MANUFACTURING RELATED ISSUE; BUT MAYBE THE CONSEQUENCE OF THE EXPLANT PROCESS. NO MANUFACTURING RELATED ISSUE FOR INCISION ENLARGED AND THE LENS NOT SEATING PROPERLY IN THE EYE, WERE SEEN IN THE RETURNED EXPLANTED LENS SAMPLE. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. (B)(4): PLACEHOLDER.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    WE RECEIVED A REPORT THAT DURING A PROCEDURE FOR IMPLANTING AN INTRAOCULAR LENS (IOL) THE LENS WOULD NOT SEAT PROPERLY AND HAD TO BE REMOVED. THE ORIGINAL INCISION HAD TO BE ENLARGED FOR REMOVAL OF THE DEVICE. PATIENT IS REPORTED TO BE DOING FINE WITHOUT ANY COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECNIS CL MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS Z9002

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention