BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSAR

    MDR report key: 3933372 · Received July 14, 2014

    Report

    Report Number
    2648035-2014-00343
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    May 21, 2014
    Report Date
    June 10, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS IMPLANTED AND REMOVED FROM THE EYE OF A PATIENT IN THE SAME PROCEDURE, DUE TO POOR DILATION. IT WAS FURTHER STATED THAT THE LENS WAS CUT OUT AND THE INCISION WAS ENLARGED. THE IOL FELL ON THE FLOOR AND WAS REPORTED TO BE LOST. THE OUTCOME DID NOT SIGNIFICANTLY INTERFERE WITH PATIENT'S DAILY ACTIVITIES AND THE PATIENT WAS REPORTED TO HAVE RECOVERED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409453 SENSAR MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS AR40E

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention