BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 1739639 · Received June 17, 2010

    Report

    Report Number
    2648035-2010-00093
    Event Type
    Injury
    Date Received
    June 17, 2010
    Date of Event
    December 17, 2007
    Report Date
    January 10, 2008
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P99080
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS (IOL) WAS RECEIVED AND THE POWER CONFIRMED TO BE CORRECT AS LABELED, 15.5 DIOPTERS. THE IOL MET ALL SPECIFICATIONS FOR OPTICAL PROPERTIES. OUR INVESTIGATION IDENTIFIED NO PRODUCT DEFICIENCY, SUGGESTING THAT THIS EVENT WAS NOT CAUSED BY THE IOL. THE TOTAL NUMBER OF EVENTS LISTED ON OUR RETROSPECTIVE REPORT SUBMISSION FOR PRODUCT CODE HQL AND THE EVENT TYPE SERIOUS INJURY IS 46. THESE EVENTS WERE NOT PREVIOUSLY REPORTED TO FDA BECAUSE THE IOL ITSELF DID NOT DIRECTLY CAUSE THE EVENT - THE EXPLANTED IOL DIOPTER POWER WAS LABELED CORRECTLY. HOWEVER, UPON FURTHER REVIEW, WE HAVE CONCLUDED THAT THESE EXPLANT REPORTS, EVEN WHEN THE DIOPTER IS CORRECTLY LABELED AND NO PRODUCT PROBLEM IS IDENTIFIED, SHOULD BE REPORTED AS MDRS DUE TO THE SECONDARY SURGICAL PROCEDURE. (B)(4).

    Description of Event or Problem · 1

    A REPORT RECEIVED FROM THE SURGEON STATED THAT A PT'S INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED WITHOUT COMPLICATION 3 WEEKS AFTER THE INITIAL IMPLANT. THE CAUSE OF THE IOL EXPLANT WAS UNEQUAL REFRACTIVE ERRORS IN THE TWO EYES. THE PT WAS MORE THAN ONE DIOPTER NEARSIGHTED IN ONE EYE AND MORE THAN ONE DIOPTER FARSIGHTED IN THE FELLOW EYE. THE ORIGINAL IMPLANT IN THE LEFT EYE WAS REPLACED WITH A HIGHER DIOPTER IOL OF THE SAME MODEL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other