BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 2240434 · Received September 9, 2011

    Report

    Report Number
    2648035-2011-00201
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    August 8, 2011
    Report Date
    August 10, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P990080
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS WAS RECEIVED AND IS CURRENTLY UNDER EVALUATION AT THE MANUFACTURING SITE. THE LENS MET ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. A REVIEW OF THE MANUFACTURER'S IMPLANT DATABASE SHOWS THE ORIGINAL IMPLANT WAS REPLACED WITH A LOWER DIOPTER LENS OF THE SAME MODEL. OUR INVESTIGATION SUGGESTS THIS EVENT IS NOT RELATED TO THE IOL. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED. SHOULD NEW INFORMATION BE RECEIVED THAT CHANGES THE FACTS AND/OR CONCLUSION OF THIS REPORT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE RETURNED IOL WAS MEASURED FOR DIOPTER AND CONFIRMED THAT IS CORRECT AS LABELED, 21.5 D. THE IOL MET ALL SPECIFICATIONS FOR OPTICAL PROPERTIES. OUR INVESTIGATION IDENTIFIED NO PRODUCT DEFICIENCY, SUGGESTING THAT THIS EVENT WAS NOT CAUSED BY THE IOL. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED. SHOULD NEW INFORMATION BE RECEIVED THAT CHANGES THE FACTS AND/OR CONCLUSION OF THIS REPORT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED 4 MONTHS AFTER IMPLANT. REASON STATED WAS IMPROPER IOL POWER. NO PATIENT COMPLICATIONS.

    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 53 YR Required Intervention