BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 2233598 · Received September 2, 2011

    Report

    Report Number
    9614546-2011-00078
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 30, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS WAS DISCARDED BY THE ACCOUNT AND NOT RETURNED FOR ANALYSIS. LENS MET ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. INITIAL REPORT STATED THIS EVENT WAS CAUSED BY A REFRACTIVE ERROR. A REVIEW OF THE MANUFACTURER'S IMPLANT DATABASE CONFIRMED THE INITIAL IMPLANT WAS REPLACED WITH A HIGHER DIOPTER LENS OF THE SAME MODEL SUGGESTING THIS EVENT WAS NOT CAUSED BY A DEFICIENT LENS. 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. LENS DISCARDED AT SURGERY CENTER.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A MULTIFOCAL INTRAOCULAR LENS IMPLANTED. POST OPERATIVE HE HAD A REFRACTIVE ERROR OF +1.5 AND IS UNHAPPY WITH HIS READING AND DISTANCE VISION. PATIENT REQUESTED SURGICAL CORRECTION. LENS WAS REMOVED AND REPLACED WITH A HIGHER DIOPTER LENS OF THE SAME MODEL 4 MONTHS AFTER IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECNIS MULTIFOCAL INTRAOCULAR LENS MFK ABBOTT MEDICAL OPTICS ZMB00

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention