BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS CL

    MDR report key: 2060416 · Received April 16, 2011

    Report

    Report Number
    2648035-2011-00069
    Event Type
    Injury
    Date Received
    April 16, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 17, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040/R003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED INTRAOCULAR LENS (IOL) WAS ANALYZED BY FOURIER TRANSFORM INFRARED (FTIR) SPECTROSCOPY IN ORDER TO IDENTIFY THE REPORTED "SMUDGE" ON THE SURFACE OF THE LENS. THE SMUDGE WAS EASILY LIFTED OFF AND APPEARED AS A TRANSLUCENT THIN FILM. EDX OF THE RESIDUE SHOWS PRIMARILY SODIUM (NA) AND CHLORINE (CL). THE SPECTRUM OF THIS SMUDGE IS IDENTICAL TO THE REFERENCE SPECTRUM FOR SODIUM HYALURONATE A DEVICE ROUTINELY USED DURING CATARACT SURGERY WITH IOL IMPLANTATION. OUR INVESTIGATION IDENTIFIED NO PRODUCT DEFICIENCY, SUGGESTING THAT THIS EVENT WAS NOT CAUSED BY THE IOL. ALL KNOWN INFORMATION IS INCLUDED IN THIS REPORT.

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS WAS RECEIVED AND IS CURRENTLY UNDER EVALUATION AT AN INDEPENDENT LABORATORY. LENS MET ALL SPECIFICATIONS PRIOR TO RELEASE. NO CONCLUSION CAN BE REACHED AT THIS TIME AS THE DEVICE IS STILL UNDERGOING ANALYSIS ALL INFORMATION AVAILABLE IS INCLUDED IN THIS REPORT. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGERY CENTER THAT SMEAR HAD DEVELOPED ON THE INTRAOCULAR LENS THAT COULD NOT BE CLEANED OFF, LENS WAS EXPLANTED 3 WEEKS AFTER IMPLANTATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention