BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 2152294 · Received July 7, 2011

    Report

    Report Number
    2648035-2011-00129
    Event Type
    Injury
    Date Received
    July 7, 2011
    Report Date
    June 8, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P99080/S06
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED IOL WAS MEASURED FOR DIOPTER AND WAS CORRECT AS LABELED, 20.0D. THE IOL MET ALL SPECIFICATIONS FOR OPTICAL PROPERTIES. OUR INVESTIGATION IDENTIFIED NO PRODUCT DEFICIENCY, SUGGESTING THAT THIS EVENT WAS NOT CAUSED BY THE IOL. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO DEVIATIONS. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED. SHOULD NEW INFORMATION THAT CHANGES THE FACTS AND/OR CONCLUSION OF THIS REPORT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4) - THE RETURNED IOL IS UNDERGOING ANALYSIS AT THE MANUFACTURING SITE. LENS MET ALL SPECIFICATIONS PRIOR TO RELEASE. SURGERY DATES WERE NOT REPORTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE REPORTER HAVE NOT BEEN SUCCESSFUL. 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

    THE SURGEON REPORTED THAT HE BELIEVES THE INTRAOCULAR LENS IS ANOTHER DIOPTER OTHER THAN WHAT IS LABELED. THE LENS WAS EXPLANTED 5 DAYS AFTER IMPLANT. DATE OF SURGERIES WERE NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECNIS MONOFOCAL INTRAOCULAR LENS HQL ABBOTT MEDICAL OPTICS ZA9003

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention