BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSAR

    MDR report key: 3031737 · Received April 2, 2013

    Report

    Report Number
    2648035-2013-00146
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    December 18, 2012
    Report Date
    March 18, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA SECTION MODEL # AR40E. ADDITIONAL INFORMATION: THE INTRAOCULAR LENS (IOL) WAS RETURNED TO THE MANUFACTURER. VISUAL INSPECTION OF THE LENS REVEALED SURFACE RESIDUALS, PARTICLES AND FIBERS ADHERED TO BOTH SIDES OF OPTIC BODY WHICH INDICATES THAT LENS WAS HANDLED IN AN UNSTERILE ENVIRONMENT. DIOPTER VERIFICATION SHOWED THAT THE LENS LENS DIOPTER CORRESPONDS TO A 2.5 DIOPTER LENS. THE PRODUCT MET THE ACCEPTANCE CRITERIA. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN IMPLANTATION OF AN INTRAOCULAR LENS (IOL) IN THE RIGHT OPTIC WHICH WAS REMOVED AND REPLACED IN A SECONDARY PROCEDURE DUE TO UNEXPECTED POST OP REFRACTIVE ERROR. PATIENT WAS NOTED TO BE DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134899 SENSAR MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS AR40M

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention