BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSAR

    MDR report key: 2946121 · Received February 6, 2013

    Report

    Report Number
    2648035-2013-00081
    Event Type
    Injury
    Date Received
    February 6, 2013
    Report Date
    January 15, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    Removal / Correction Number
    2648035-01-03-13-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 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 INTRAOCULAR LENS WAS EXPLANTED. DURING EXPLANT, AFTER THE LENS HAD BEEN CUT, A FRAGMENT OF THE LENS FELL INTO THE VITREOUS. THE PATIENT IS FINE, NO PROBLEMS WERE REPORTED; A VITRECTOMY WAS PERFORMED. NO ADDITIONAL INFORMATION REGARDING PATIENT STATUS WAS PROVIDED. THE IMPLANT AND EXPLANT DATES FOR THE INTRAOCULAR LENS WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50492 SENSAR MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS AR40E

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention