BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1-PIECE

    MDR report key: 3202672 · Received July 2, 2013

    Report

    Report Number
    2648035-2013-00274
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 19, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION: YES RECEIVED 6/26/13. (B)(4). CLARIFICATION: THE INTRAOCULAR LENS WAS RETURNED UNDER A RETURNED GOODS AUTHORIZATION THAT DID NOT INDICATE THE LENS HAD BEEN EXPLANTED. THEREFORE, IT WAS DESTROYED AND NOT SUBMITTED FOR INVESTIGATION. THERE WAS NO QUALITY ISSUE WITH THE IOL; THE DOCTOR IMPLANTED THE WRONG TYPE OF LENS (MONOFOCAL). ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT IMPLANTATION OF AN INTRAOCULAR LENS (IOL) WHICH WAS EXPLANTED IN A SECONDARY PROCEDURE. IT WAS REPORTED THAT THE PATIENT WANTED A ZMB00 (MULTIFOCAL LENS), HOWEVER, RECEIVED A ZCB00 (MONOFOCAL LENS). IN ADDITION, IT WAS NOTED THAT THERE WERE NO COMPLICATIONS. THERE WAS NO INCISION ENLARGEMENT AND NO VITRECTOMY REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301449 TECNIS 1-PIECE MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention