BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 3790987 · Received May 5, 2014

    Report

    Report Number
    2648035-2014-00211
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 23, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE LENS WAS RECEIVED AT THE MANUFACTURER AND OBSERVED TO BE CUT INTO TWO PARTS. LOOSE PARTICLES WERE OBSERVED ON THE LENS OPTIC BODY COMPATIBLE WITH HANDLING THE LENS OUT OF THE STERILE ENVIRONMENT. THE LENS CONDITION IS CONSISTENT WITH A LENS THAT HAS BEEN EXPLANTED FROM THE PATIENT'S EYE. THE SAMPLE WAS OBSERVED WITH THE CHARACTERISTIC OF A ZMB00 LENS AS A CIRCULAR ZONE ACROSS THE OPTIC WAS DETECTED. DIOPTER MEASUREMENT COULD NOT BE PERFORMED DUE TO THE RECEIVED CONDITION OF THE LENS. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION - YES. DEVICE RETURNED TO MANUFACTURER ON 5/21/2014. THE MANUFACTURING RECORD REVIEW INDICATED THAT ALL PROCESS OPERATIONS WERE IN COMPLIANCE WITH MANUFACTURING PROCEDURE SPECIFICATIONS. THE DOCUMENTATION SHOWS THAT THE PRODUCTION ORDER WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DATE OF THIS REPORT: (B)(6) 2014. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TECNIS MULTIFOCAL LENS MODEL ZMB00 WAS IMPLANTED IN THE PATIENT'S LEFT EYE AND THAT THE PATIENT WAS VERY UNHAPPY WITH THEIR OUTCOME. IT WAS STATED THAT THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND REPLACED WITH A MONOFOCAL LENS. THE PATIENT CAME IN FOR A ONE DAY POST OPERATIVE CHECK-UP ON (B)(6) 2014 AND WAS REPORTED TO BE DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266690 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZMB00

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention