BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS CL

    MDR report key: 2821841 · Received November 6, 2012

    Report

    Report Number
    2648035-2012-00348
    Event Type
    Injury
    Date Received
    November 6, 2012
    Report Date
    October 18, 2012
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P880081
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. (B)(4): PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(4).ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS INC HAS BEEN SUBMITTED. (B)(4): PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS INC HAS BEEN SUBMITTED. (B)(4): PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING SYMPTOMS OF DIPLOPIA, BLURRY VISION, AND WEAKNESS. PATIENT HAD INTRAOCULAR LENS (IOL) IMPLANTED IN THE RIGHT OPTIC ON (B)(6), 2010. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECNIS CL MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS Z9002

    Patients

    Seq Age Sex Outcome Treatment
    1 Other