BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS MULTIFOCAL

    MDR report key: 2213697 · Received August 16, 2011

    Report

    Report Number
    9614546-2011-00070
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 19, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P080010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ONE HALF OF THE INTRAOCULAR LENS WAS RECEIVED FOR ANALYSIS. INSPECTION SHOWS ONE BROKEN HAPTIC. THE LENS MET ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE TO MARKET. 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

    IT WAS REPORTED BY A NURSE THAT THE INTRAOCULAR LENS WAS DAMAGED DURING INSERTION DUE TO A LOADING ERROR. INCISION WAS ENLARGED TO REMOVE THE LENS FROM THE PATIENT'S EYE. NO PATIENT ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECNIS MULTIFOCAL MULTIFOCAL INTRAOCULAR LENS MFK ABBOTT MEDICAL OPTICS ZMA00

    Patients

    Seq Age Sex Outcome Treatment
    1 Other