BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS MULTIFOCAL

    MDR report key: 1820966 · Received August 31, 2010

    Report

    Report Number
    9614546-2010-00047
    Event Type
    Injury
    Date Received
    August 31, 2010
    Date of Event
    July 27, 2010
    Report Date
    August 2, 2010
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P080010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS WAS NOT YET RECEIVED FOR ANALYSIS. THE IOL MET ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. ADDITIONAL INFORMATION WILL BE SUBMITTED FOLLOWING ANALYSIS OF THE IOL.

    Description of Event or Problem · 1

    DURING POSTOPERATIVE EXAM FOLLOWING ROUTINE CATARACT EXTRACTION WITH INTRAOCULAR LENS IMPLANT, THE PHYSICIAN OBSERVED A CRIMPED HAPTIC ON THE LENS. THE LENS WAS EXPLANTED 2 WEEKS AFTER IMPLANT WITHOUT COMPLICATION OR PATIENT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention