BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSAR

    MDR report key: 2922631 · Received January 18, 2013

    Report

    Report Number
    2648035-2013-00011
    Event Type
    Injury
    Date Received
    January 18, 2013
    Date of Event
    November 26, 2012
    Report Date
    December 29, 2012
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Removal / Correction Number
    2648035-01-03-13-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE PLACEMENT OF A SECOND LENS SATISFACTORILY RESOLVED THE PATIENT''S VISUAL PROBLEMS.ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. H3 (B)(4): PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(6). (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 ABBOTT MEDICAL OPTICS 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 A DIOPTER MIX-UP BETWEEN TWO LOTS. IT WAS STATED THAT THE PATIENT UNDERWENT A SECONDARY PROCEDURE DUE TO UNEXPECTED POST OP REFRACTION WHEREBY A SECOND INTRAOCULAR LENS (IOL) WAS IMPLANTED AS A PIGGYBACK ON (B)(6) 2012. NO ADDITIONAL INFORMATION REGARDING PATIENT STATUS WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28056 SENSAR MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS AR40E

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention