BEUDAMED
    FDA Adverse Event Other Summary report: N

    TECNIS ACRYLIC

    MDR report key: 1033543 · Received April 22, 2008

    Report

    Report Number
    2648035-2008-00013
    Event Type
    Other
    Date Received
    April 22, 2008
    Report Date
    March 20, 2008
    Manufacturer
    ADVANCED MEDICAL OPTICS
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL OF THE LENS IN QUESTION SHOWS IT APPEARS TO BE A SILICONE MATERIAL AND NOT ACRYLIC AS LABELED. CONCENTRIC CIRCLES WITHIN THE LENS WERE NOTED AND ARE SIMILAR TO AN AMO MULTIFOCAL IOL. PROD HISTORY RECORDS INDICATE THE PROD MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REC'D FOR THIS PRODUCTION RECORD. THE MFR'S INVESTIGATION INTO THIS EVENT CONTINUES.

    Description of Event or Problem · 1

    THE MFR BECAME AWARE OF THIS EVENT WHEN DATA FOR AN AMO INTRAOCULAR LENS WAS PRESENTED IN THE PUBLIC DOMAIN ON ANOTHER IOL MFR'S WEBSITE. THE LENS IN QUESTION WAS USED DURING A STUDY CONDUCTED BY THIS MFR, IT WAS NOT IMPLANTED. DURING A REVIEW OF THIS STUDY DATA, IT WAS NOTED BY THE IOL MFR THAT THE MTF DATA PRESENTED FOR THE AMO TECNIS ACRYLIC LENS ON THE WEBSITE IS INCONSISTENT WITH DATA GENERATED BY THE MFR FOR MTF PERFORMANCE FOR THIS LENS MODEL. FURTHER INVESTIGATION OF THIS EVENT AND A SITE VISIT BY AMO PERSONNEL TO THE OTHER MFR SHOW THAT A SILICONE MULTIFOCAL LENS WAS CONTAINED WITHIN THE CARTON OF TECNIS ACRYLIC INTRAOCULAR LENS. AN INVESTIGATION AT THE MFG SITE SHOWED THAT SILICONE AND ACRYLIC LENSES ARE MANUFACTURED IN SEPARATE MFG BUILDING/FACILITIES. THE ACRYLIC PRODUCTION ORDER CONTAINED ALL LENSES, SOLD WORLDWIDE. NO ADD'L COMPLAINTS WERE REC'D FOR THE REMAINING LENSES IN THIS PROD ORDER. IN ADDITION 96% OF THE LENSES SOLD IN THE USA WERE REPORTED AS IMPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1