BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS CL

    MDR report key: 2859274 · Received December 5, 2012

    Report

    Report Number
    2648035-2012-00374
    Event Type
    Injury
    Date Received
    December 5, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 20, 2012
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P880081
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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

    TWO HALVES OF THE LENS WERE RETURNED FOR INVESTIGATION. THE RETURNED HALVES WERE INSPECTED AT 10X MICROSCOPE MAGNIFICATION. THE LENS HAD SURFACE RESIDUALS ADHERED TO BOTH SIDE OF OPTIC BODY THAT WERE COMPATIBLE WITH THE EXPLANT PROCESS. OPTICAL MEASUREMENT: TWO HALVES OF LENS WERE JOINED FOR TESTING PURPOSE. OPTICAL INSPECTION RESULTS SHOWED THAT THE LENS DIOPTER CORRESPOND TO A 23.5 DIOPTER LENS, WHICH MET PRODUCT SPECIFICATIONS.(B)(4): PLACEHOLDER.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT CONCERNING A PATIENT WHO AN INTRAOCULAR LENS (IOL) EXPLANTED DUE TO NOT BEING SATISFIED WITH THE VISUAL OUTCOME. NO PATIENT INJURY WAS REPORTED.

    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 76 YR Required Intervention