BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSAR

    MDR report key: 2942295 · Received February 4, 2013

    Report

    Report Number
    2648035-2013-00075
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Report Date
    January 11, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Removal / Correction Number
    2648035-01-03-13-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THE PRIMARY CAUSE FOR THIS EVENT WAS THE INADVERTENT SWITCHING OF THE DEVICE HISTORY RECORD (DHR) LABELING POUCHES BETWEEN THE TWO TOTES OF IMPACTED LENSES ON AN IN-PROCESS STORAGE RACK. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN IMPLANTATION OF AN INTRAOCULAR LENS (IOL) WHICH IS PART OF A PRODUCT RECALL. ABBOTT ISSUED THE PRODUCT RECALL DUE TO A DIOPTER MIX-UP BETWEEN TWO LOTS. THE PATIENT REPORTEDLY IS DOING FINE AND HAS RETURNED FOR FOLLOW UP. THE PATIENT INDICATED THEY PREFER TO TRY SPECTACLES TO CORRECT THEIR VISION FOR NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46559 SENSAR MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS AR40E

    Patients

    Seq Age Sex Outcome Treatment
    1 Other