BEUDAMED
    FDA Adverse Event Other Summary report: N

    TECNIS MULTIFOCAL

    MDR report key: 2389255 · Received December 21, 2011

    Report

    Report Number
    2648035-2011-00305
    Event Type
    Other
    Date Received
    December 21, 2011
    Date of Event
    December 2, 2011
    Report Date
    December 2, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P080010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS WAS RECEIVED FOR ANALYSIS. INSPECTION SHOWS A LENS CUT IN 2 PIECES WITH 2 BROKEN HAPTICS. THE CONDITION OF THE LENS SUGGESTS THE DAMAGE IS NOT RELATED TO THE MANUFACTURING PROCESS. 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 INTRAOCULAR LENS WAS NOT RECEIVED FOR ANALYSIS AT THE TIME OF SUBMITTING THE MEDICAL DEVICE REPORT. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS (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 THAT THE HAPTIC BENT AS THE INTRAOCULAR LENS WAS BEING IMPLANTED. THE INCISION WAS ENLARGED TO REMOVE THE LENS WITHOUT PATIENT INJURY.

    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 Required Intervention