BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 3913213 · Received July 3, 2014

    Report

    Report Number
    2648035-2014-00327
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    July 3, 2014
    Report Date
    June 9, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER TAPED TO A PIECE OF CARDBOARD. IT COULD NOT BE PRIED OFF AND EVALUATED. THE MANUFACTURING RECORDS WERE REVIEWED. ALL PROCESS OPERATIONS PRESENTED IN THE MANUFACTURING RECORD FROM GENERATION TO BOXING WERE IN COMPLIANCE WITH MANUFACTURING INSTRUCTIONS SPECIFICATIONS. ALL TESTS RESULTS SHOWED A PASS CONDITION. NO DEVIATION OR NON-CONFORMANCE (NCR) RELATED TO THE CUSTOMER CLAIM WAS GENERATED WHEN THIS PRODUCTION ORDER WAS MANUFACTURED. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    IN FOLLOW UP IT WAS CONFIRMED THAT THE EXPLANT OF THE INTRAOCULAR LENS (IOL) TOOK PLACE AS SCHEDULED ON (B)(6) 2014. THE ORIGINAL INCISION WAS ENLARGED FROM 2.4MM TO 2.75 MM TO REMOVE THE IOL. PATIENT WAS IMPLANTED WITH A MONOFOCAL DURING THE SAME PROCEDURE. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT THAT A PATIENT EXPERIENCED HALOS AND GLARE FOR OVER THREE MONTHS AFTER BEING IMPLANTED WITH AN ZMB00 16.5 DIOPTER INTRAOCULAR LENS (IOL). THE SYMPTOMS WERE BOTHERSOME ENOUGH THAT A EXPLANT PROCEDURE WAS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390003 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZMB00

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other