BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 6119111 · Received November 21, 2016

    Report

    Report Number
    9614546-2016-00618
    Event Type
    Injury
    Date Received
    November 21, 2016
    Report Date
    November 21, 2016
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    UDI-DI
    05050474560024
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO INDICATION AT THE TIME OF THIS REPORT THAT THE LENS HAS BEEN EXPLANTED. (B)(4). DEVICE EVALUATION: THE INTRAOCULAR LENS (IOL) WAS NOT RETURNED AT THE MANUFACTURING SITE FOR EVALUATION. THE COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS WERE REVIEWED. DURING THE MANUFACTURING RECORD REVIEW OF THE PRODUCTION ORDER FOR THIS SERIAL NUMBER, NO PRODUCT DEFICIENCY WAS IDENTIFIED. THE DOCUMENTATION SHOWS THAT THE PRODUCTION ORDER WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. A SEARCH REVEALED THAT NO ADDITIONAL COMPLAINTS FOR THIS ORDER NUMBER HAVE BEEN RECEIVED. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WERE REVIEWED. THE DIRECTIONS FOR USE (DFU) ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS ALONG WITH WARNINGS FOR THE PROPER USE AND HANDLING OF THE DEVICE. BASED ON REVIEW, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6) 2016, IT WAS REPORTED THAT A PATIENT IS EXTREMELY UNHAPPY WITH THE RESULTS AND COMPLAINED ABOUT HALOS AFTER IMPLANTATION OF A ZKB00 INTRAOCULAR LENS (IOL). REPORTEDLY, PHYSICIAN STATED THAT THE PATIENT IS 20/20, AND HE COULDN'T ASK FOR A BETTER RESULT CLINICALLY. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2016 STATING THAT AS OF LAST WEEK, PATIENT IS STILL 20/20 IN BOTH EYES, BUT STILL VERY FRUSTRATED WITH GLARE IN BOTH EYES. THIS REPORT REPRESENTS THE LENS IMPLANTED IN PATIENT'S LEFT EYE. A SEPARATE REPORT IS BEING FILED FOR THE LENS IMPLANTED IN PATIENT'S RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768080 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZKB00 05050474560024

    Patients

    Seq Age Sex Outcome Treatment
    1 Other